Systems and methods for removing obstructive matter from body lumens and treating vascular defects

ABSTRACT

Systems and methods for removing obstructions from, delivering implantable devices or substances in or near and/or restoring flow through body lumens, such as blood vessel lumens. A catheter having a proximal portion of a first diameter and a distal portion of a second diameter (smaller than the first diameter) is advanced into a body lumen. The distal portion of the catheter is caused to expand to a diameter that is larger than the second diameter but no larger than the first diameter. A working device is then advanced out of the distal end of the catheter and used to remove obstructive matter, deliver an implantable device or substance and/or restore flow. The distal portion can be reduced in diameter prior to removal from the body.

RELATED APPLICATIONS

This application is a national stage of PCT international applicationPCT/US2009/069498 which is an international application designating theUnited States and claims the benefit of and priority to U.S. patentapplication Ser. No. 12/343,374, filed Dec. 23, 2008, now U.S. Pat. No.8,425,549.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methodsand more particularly to catheter-based systems and methods useable forremoving obstructions from or treating defects in blood vessels, such asblood vessels of the brain.

BACKGROUND OF THE INVENTION

Stroke is a common cause of death in the United States and disablingneurologic disorder. Approximately 700,000 patients suffer from strokeannually. Stroke is a syndrome characterized by the acute onset of aneurological deficit that persists for at least 24 hours, reflectingfocal involvement of the central nervous system, and is the result of adisturbance of the cerebral circulation. Its incidence increases withage. Risk factors for stroke include systolic or diastolic hypertension,hypercholesterolemia, cigarette smoking, heavy alcohol consumption, andoral contraceptive use.

Hemorrhagic stroke accounts for 20% of the annual stroke population.Hemorrhagic stroke often occurs due to rupture of an aneurysm orarteriovenous malformation (AVM), causing bleeding into the brain tissueand resultant infarction of brain tissue. The remaining 80% of thestroke population are ischemic strokes and are caused by occludedvessels that deprive the brain of oxygen-carrying blood. Ischemicstrokes are often caused by emboli or pieces of thrombotic tissue thathave dislodged from other body sites or from the cerebral vesselsthemselves to occlude in the narrow cerebral arteries more distally.When a patient presents with neurological symptoms and signs, whichresolve completely within 1 hour, the term transient ischemic attack(TIA) is used. Etiologically, TIA and ischemic stroke share the samepathophysiologic mechanisms and thus represent a continuum based onpersistence of symptoms and extent of ischemic insult.

Emboli occasionally form around the valves of the heart or in the leftatrial appendage during periods of irregular heart rhythm and then aredislodged and follow the blood flow into the distal regions of the body.Those emboli can pass to the brain and cause an embolic stroke. As willbe discussed below, many such occlusions occur in the middle cerebralartery (MCA), although such is not the only site where emboli come torest.

When a patient presents with neurological deficit, a diagnostichypothesis for the cause of stroke can be generated based on thepatient's history, a review of stroke risk factors, and a neurologicexamination. If an ischemic event is suspected, a clinician cantentatively assess whether the patient has a cardiogenic source ofemboli, large artery extracranial or intracranial disease, small arteryintraparenchymal disease, or a hematologic or other systemic disorder. Ahead CT scan is often performed to determine whether the patient hassuffered an ischemic or hemorrhagic insult. Blood would be present onthe CT scan in subarachnoid hemorrhage, intraparenchymal hematoma, orintraventricular hemorrhage.

Traditionally, emergent management of acute ischemic stroke consistedmainly of general supportive care, e.g. hydration, monitoringneurological status, blood pressure control, and/or anti-platelet oranti-coagulation therapy. In 1996, the Food and Drug Administrationapproved the use of Genentech Inc.'s thrombolytic drug, tissueplasminogen activator (t-PA) or Activase®, for treating acute stroke. Arandomized, double-blind trial, the National Institute of NeurologicalDisorders and t-PA Stroke Study, revealed a statistically significantimprovement in stroke scale scores at 24 hours in the group of patientsreceiving intravenous t-PA within 3 hours of the onset of an ischemicstroke. Since the approval of t-PA, an emergency room physician could,for the first time, offer a stroke patient an effective treatmentbesides supportive care.

However, treatment with systemic t-PA is associated with increased riskof intracerebral hemorrhage and other hemorrhagic complications.Patients treated with t-PA were more likely to sustain a symptomaticintracerebral hemorrhage during the first 36 hours of treatment. Thefrequency of symptomatic hemorrhage increases when t-PA is administeredbeyond 3 hours from the onset of a stroke. Besides the time constraintin using t-PA in acute ischemic stroke, other contraindications includethe following: if the patient has had a previous stroke or serious headtrauma in the preceding 3 months, if the patient has a systolic bloodpressure above 185 mmHg or diastolic blood pressure above 110 mmHg, ifthe patient requires aggressive treatment to reduce the blood pressureto the specified limits, if the patient is taking anticoagulants or hasa propensity to hemorrhage, and/or if the patient has had a recentinvasive surgical procedure. Therefore, only a small percentage ofselected stroke patients are qualified to receive t-PA.

Obstructive emboli have also been mechanically removed from varioussites in the vasculature for years. For example, the “Fogarty catheter”or variations thereof has been used, typically in the periphery, toremove clots from arteries found in legs and in arms. These well knowndevices are described, for example, in U.S. Pat. No. 3,435,826, toFogarty and in U.S. Pat. Nos. 4,403,612 and 3,367,101. In general, thesepatents describe a balloon catheter in which a balloon material islongitudinally stretched when deflated.

In procedures for removing emboli using the Fogarty catheter or othersimilar catheters, it is typical, first, to locate the clot usingfluoroscopy. The embolectomy catheter is then inserted and directed tothe clot. The distal tip of the balloon catheter is then carefully movedthrough the center of the clot. Once the balloon has passed through thedistal side of the clot, the balloon is inflated. The balloon catheteris then gradually proximally withdrawn. The balloon, in this way, actsto pull the clot proximally ahead of the balloon to a point where it canbe retrieved. The majority of procedures using a Fogarty type catheterrepeat these steps until the pertinent vessel is cleared of clotmaterial.

A variety of alternative emboli retrieval catheters have also beendeveloped, in which various wire corkscrews and baskets must be advanceddistally through the embolic material in order to achieve capture andremoval. However, removal of emboli using such catheters carriesattendant potential problems. One such problem occurs when advancing thecatheter through the clot dislodges material to a more remote site whereremoval may become more difficult or impossible.

Although neurointerventional devices and procedures have advanced, thereremains a need for expeditious restoration of distal flow to blocked, orstenotic, cerebrovascular vessels, which can lead to severe neurologicaldeficit or patient death.

New devices and methods are thus needed in treating vasculatureocclusions in the body, including patients with acute ischemic strokeand occlusive cerebrovascular disease, in treating symptomatic patientswith embolization or hemodynamic compromise, or in stroke prevention,e.g., patients with incidental finding of asymptomatic carotid lesion,which improve a patient's neurological function and quality of lifewithout causing significant side effect, and can thus also be used inpatients with contraindication to the use of t-PA.

SUMMARY OF THE INVENTIONS

In accordance with one aspect of the present invention, there isprovided a system useable for performing a therapeutic or diagnostictask at a location within the body of a human or animal subject, suchsystem comprising a) catheter that has a proximal portion, a distalportion, a lumen and a distal end opening, said catheter beingtransitionable from a first configuration wherein the distal portion hasa first outer diameter that is smaller than the outer diameter of theproximal portion and a second configuration wherein the distal portionis expanded to a second outer diameter that is larger than the firstouter diameter and no larger than the outer diameter of the proximalportion and b) a working device that is advanceable though the lumen ofthe catheter and out of its distal opening at least when the distalportion of the catheter is in is second configuration, said workingdevice being useable to perform the therapeutic or diagnostic task.Examples of the types of working devices that may be used in this systeminclude but are but are not limited to; i) devices for removing thrombusor other obstructive matter from body lumens, ii) flow restorationdevices useable to facilitate flow of a fluid though or around anobstruction within a body lumen and iii) devices for deploying ordelivering implants (e.g., implantable occlusion coils or implantableembolic devices).

Further in accordance with the invention, there is provided a method forperforming a therapeutic or diagnostic task at a location within thebody of a human or animal subject, such method comprising the steps of:a) inserting into the subject's body a catheter that has a proximalportion, a distal portion, a lumen and a distal end opening, saidcatheter being transitionable from a first configuration wherein thedistal portion has a first outer diameter that is smaller than the outerdiameter of the proximal portion and a second configuration wherein thedistal portion is expanded to a second outer diameter that is largerthan the first outer diameter and no larger than the outer diameter ofthe proximal portion; b) positioning the distal end opening in a desiredbody lumen while the distal portion of the catheter is in its firstconfiguration; c) causing the distal portion of the catheter totransition to its second configuration; d) advancing a working devicethough the lumen of the catheter and out of its distal opening; and,using the working device to perform the therapeutic or diagnostic task.Examples of the types of working devices that may be used in this methodinclude but are but are not limited to; devices for removing thrombus orother obstructive matter from body lumens, flow restoration devicesuseable to restore blood flow though an obstructed body lumen anddevices for delivering implants (e.g., implantable occlusion coils orembolic devices).

Still further in accordance with the invention there is provided amethod for removing obstructive matter from a body lumen, such methodcomprising the steps of: a) inserting a catheter that has a proximalportion, a distal portion, a lumen and a distal end opening, saidcatheter being transitionable from a first configuration wherein thedistal portion has a first outer diameter that is smaller than the outerdiameter of the proximal portion and a second configuration wherein thedistal portion is expanded to a second outer diameter that is largerthan the first outer diameter and no larger than the outer diameter ofthe proximal portion; b) positioning the catheter, while in the firstconfiguration, such that its distal end opening is within a body lumen;c) causing the catheter to transition from the first configuration tothe second configuration; d) moving obstructive matter through thedistal end opening and into the lumen of the catheter; and e) removingthe catheter along with the obstructive matter that has been moved intothe lumen of the catheter. In some embodiments, negative pressure may beapplied through the lumen of the catheter to aspirate obstructive matterthrough the distal end opening and into the lumen of the catheter. Insome embodiments Step D of the method may comprise advancing anobstructive matter moving device (e.g., an embolectomy device) from thecatheter and using the obstructive matter moving device to moveobstructive matter through the distal end opening and into the lumen ofthe catheter. One non-limiting example of the types of obstructivematter moving device that may be used is a device having an expandableelement that is expanded within the body lumen such that obstructivematter becomes entrained in or engaged by the expandable element in amanner that allows it to thereafter move some or all of the obstructivematter. Such expandable element is then retracted, along withobstructive matter that has become entrained in or engaged by theexpandable member, through the distal end opening and into the lumen ofthe catheter. In some cases the method may further include the step ofdelivering a therapeutic substance. For example, in cases where theobstructive matter comprises thrombus, a thrombolytic agent or othersubstance that will dissolving some of the thrombus and/or deteradherence of the thrombus to a wall of the body lumen may be delivered.In some embodiments where an obstructive matter moving device is used,such obstructive matter moving device is used to move the obstructivematter into the catheter, the obstructive matter moving device mayinitially be used to canalize or compress the obstructive matter in amanner that improves blood flow through or around the obstructive matterfor a period of time and, thereafter, is used to move at least some ofthe obstructive matter through the distal opening and into the lumen ofthe catheter.

Still further in accordance with the present invention, there isprovided a method for increasing flow of a body fluid through anobstructed body lumen, such method comprising the steps of: a) insertinga catheter that has a proximal portion, a distal portion, a lumen and adistal end opening, said catheter being transitionable from a firstconfiguration wherein the distal portion has a first outer diameter thatis smaller than the outer diameter of the proximal portion and a secondconfiguration wherein the distal portion is expanded to a second outerdiameter that is larger than the first outer diameter and no larger thanthe outer diameter of the proximal portion; b) positioning the catheter,while in the first configuration, such that its distal end opening iswithin a body lumen; c) causing the catheter to transition from thefirst configuration to the second configuration; and d) using thecatheter to deliver a treatment that restores or improving flow of abody fluid through an obstructed body lumen. In some embodiments, thetreatment delivered may comprise the delivery of a therapeutic substance(e.g., a thrombolytic agent) of a type and in an amount that iseffective to improve flow of body fluid through the body lumen. In someembodiments, the treatment delivered may comprise use of a device thatcanalizes or compresses obstructive matter in a manner that improvesflow of body fluid through or around the obstructive matter.

In some embodiments, the therapeutic catheter can comprise radiopaquemarkers that are configured to be monitored under fluoroscopy. Theseradiopaque markers can be affixed to an expandable region of the devicesuch that the amount of expansion can be visualized by movement of theradiopaque markers in a direction lateral to the longitudinal axis ofthe therapeutic catheter. In other embodiments, an indirect evaluationof device lateral expansion can be achieved by monitoring alongitudinally translating expansion-control element of the devicerelative to a stationary element of the device, both elements depictedby affixed radiopaque markers.

In certain embodiments, the therapeutic catheter can be used to injectangiographic dye into the lumen of a vessel within which the catheter isdisposed. Dye injection lumens can be operably connected to dye exitports at the distal end of the therapeutic catheter. Dye injectionlumens can also be operably connected to dye exit ports disposed atintervals along the length of the catheter near its distal end. The dyeinjection lumens can be operably connected to dye injection ports at theproximal end of the catheter, which are accessible to connection tosyringes or other liquid pressure injection devices. The catheter can berouted through an obstruction, for example over a guidewire. Dye can beinjected so that it flows through the distal dye exit port and into thevessel lumen. Dye can further be injected such that it flows from theproximal dye exit ports. Dye exit ports disposed, or embedded, withinthe obstruction will be blocked and prevent dye exit. However dye exitports located proximally to the obstruction will permit free flow of dyeinto the vessel lumen. The visual gap between the dye that exited fromthe distal ports and the more proximal ports can provide an indicationof the extent or length of the obstruction, such as a clot or thrombus,within the vessel lumen. Flow restrictions within the guide catheter canbe added to optimize flow from the side ports given the low resistanceto flow out the distal end. Such flow restrictors can restrict, orcompletely block, flow out the distal end of the catheter and increaseflow through side ports. Side ports disposed distally to the obstructioncan serve the same function as an open central lumen port.

In other embodiments, the expandable guide catheter can be used toperform therapy. The expandable guide catheter can include a side portlocated proximal to the expandable distal region of the catheter. Theside port in the expandable guide catheter communicates fluidicallybetween the environment external to the catheter and the internal lumenof the catheter. The expandable guide catheter includes a translationdilator that also comprises at least one window that can be aligned withthe side port in the exterior of the catheter to permit fluidcommunication between the external environment adjacent the catheter andthe internal lumen of the catheter, which internal lumen residingradially inside the translation dilator. The expandable guide cathetercan further include a removable obturator or lead guidewire. Used inthis capacity, the expandable guide catheter can serve as a temporaryshunt for the vasculature or other body lumen.

The therapeutic expandable guide catheter can be advanced toward andthrough an obstruction such as a clot or region of spasm within avessel. The obstruction is penetrated by the removable obturator orguidewire and is followed by the radially collapsed distal end of theexpandable guide catheter. The obturator is removed once the obstructionis fully penetrated and the distal end of the expandable region issecurely within unobstructed vessel lumen. The translation dilator isnext advanced distally to expand the distal, expandable region and thewindow in the side wall of the translation dilator is aligned with theport or window in the proximal portion of the expandable guide catheter.In other embodiments, the obturator can remain within the translationdilator while it is being advanced distally to expand the distal,radially expandable region. Blood flow through the vessel obstructioncan be restored in this way since blood can flow into the window or portwithin the sidewall of the expandable guide catheter and flow outthrough the open distal end of the central lumen of the translationdilator. In other embodiments, blood flow can also be restored in thereverse direction.

Further aspects, embodiments, variations, details, elements and examplesof the present inventions will be understood by those of skill in therelevant art from the accompanying drawings and the following detaileddescription.

BRIEF DESCRIPTION OF THE DRAWINGS

A general architecture that implements the various features of theinvention will now be described with reference to the drawings. Thedrawings and the associated descriptions are provided to illustrate somebut not all embodiments or examples of the invention and do not limitthe scope of the claimed inventions in any way. Throughout the drawings,reference numbers are re-used to indicate correspondence betweenreferenced elements.

FIG. 1 is a side elevational schematic view of an intracranialaspiration catheter in accordance with the present invention, with adistal segment in a reduced crossing profile configuration, according toan embodiment of the invention;

FIG. 2 is a side elevational view as in FIG. 1, with the distal segmentin an enlarged cross-sectional configuration, according to an embodimentof the invention;

FIG. 3A is a cross-sectional view taken along the line 3-3 in FIG. 1,according to an embodiment of the invention;

FIG. 3B is an alternate cross-section through an intracranial aspirationcatheter having an over-the-wire configuration, according to anembodiment of the invention;

FIG. 4A is a cross-sectional view taken along the line 4-4,schematically showing a folding pattern for the distal section,according to an embodiment of the invention;

FIG. 4B is a cross-sectional view as in FIG. 4A, showing an alternatefolding pattern, according to an embodiment of the invention;

FIG. 5 is a side elevational cross-sectional view through a distalportion of the catheter of FIG. 1, illustrating an axially movablesupport coil in a proximal position, according to an embodiment of theinvention;

FIG. 6 is a cross-sectional view as in FIG. 5, with the axially movablesupport coil in a distal position, according to an embodiment of theinvention;

FIG. 7 is a cross-sectional view as in FIG. 5, showing an alternatesupport coil in a proximal position, according to an embodiment of theinvention;

FIG. 8 is a cross-sectional view as in FIG. 7, with the alternatesupport coil in a distal position, according to an embodiment of theinvention;

FIG. 9 is a schematic representation of the reversed circulation in thecircle of Willis, to compensate for an occlusion in the left carotidsiphon artery, with a guidewire extending through the left internalcarotid artery to the occlusion, according to an embodiment of theinvention;

FIG. 10 is a schematic illustration as in FIG. 9, with an intracranialaspiration catheter advanced to the occlusion, in the reduced diameterconfiguration, according to an embodiment of the invention;

FIG. 11 is a schematic representation as in FIG. 10, with the distalsection of the catheter in the enlarged diameter configuration,according to an embodiment of the invention;

FIG. 12 is a schematic representation as in FIG. 11, followingaspiration of the occlusion through the enlarged diameter of theaspiration catheter, according to an embodiment of the invention;

FIG. 13A illustrates a side view of a catheter, wherein a guidewire hasnot yet been inserted into the central catheter lumen, thus theexpandable element remains biased in it's fully expanded configuration,according to an embodiment of the invention;

FIG. 13B illustrates a side view of the catheter of FIG. 13A, wherein aguidewire is fully inserted into the catheter lumen resulting in theexpandable element being forced into its fully collapsed, minimumdiameter configuration, according to an embodiment of the intention;

FIG. 14A illustrates a detail of the distal region of the catheter ofFIG. 13A showing the guidewire constriction or aperture and a radiallyexpanded, expandable element, according to an embodiment of theinvention;

FIG. 14B illustrates a detail of the distal region of the catheter ofFIG. 13A, wherein a guidewire has been inserted through the guidewireconstriction forcing the expandable element to contract radially,according to an embodiment of the invention;

FIG. 15A illustrates a thrombus removal catheter in its minimum diameterconfiguration being advanced toward a mass of thrombus within a bloodvessel, according to an embodiment of the invention;

FIG. 15B illustrates the thrombus removal catheter of FIG. 15A, whereinthe catheter has been advanced through a central portion of the thrombussuch that a radially expandable region extends beyond both ends of thethrombus, according to an embodiment of the invention;

FIG. 15C illustrates the thrombus removal catheter of FIG. 15B, whereinthe radially expandable region has been diametrically expanded tocontact and entrap the thrombus, according to an embodiment of theinvention;

FIG. 16A illustrates the thrombus removal catheter of FIG. 15C, whereinthe radially expandable region has been re-collapsed, according to anembodiment of the invention;

FIG. 16B illustrates the thrombus removal catheter of FIG. 16A, whereinthe catheter, with entrapped thrombus material, is being withdrawn intoa funneled guide catheter, according to an embodiment of the invention;

FIG. 17 illustrates an expandable catheter expanded across acerebrovascular aneurysm for the purpose of forming a temporary neckbridge, according to an embodiment of the invention, according to anembodiment of the invention;

FIG. 18 illustrates an expandable microcatheter element placed acrossthe entrance to a cerebrovascular aneurysm, wherein the expandableelement forms a neck bridge across the opening to the main artery, withan embolic coil being deployed within the aneurysm, according to anembodiment of the invention;

FIG. 19 illustrates an expandable microcatheter element placed acrossthe entrance to a cerebrovascular aneurysm, wherein the expandableelement forms a neck bridge across the opening to the main artery, witha quantity of embolic mass being deployed within the aneurysm, accordingto an embodiment of the invention;

FIG. 20 illustrates the distal end of a microcatheter with an expandableregion placed across the entrance to an aneurysm such that a deliverycatheter is capable of deploying a coil within the aneurysm, accordingto an embodiment of the invention;

FIG. 21 illustrates the distal end of a microcatheter with itsexpandable region dilated within a length of cerebrovasculature, whereinthe catheter comprises a serpentine expandable length section within theexpandable region, according to an embodiment of the invention;

FIG. 22A illustrates a length of vasculature, partially blocked by ahard plaque formation, being approached by a microcatheter andguidewire, according to an embodiment of the invention;

FIG. 22B illustrates the microcatheter of FIG. 22A having been advancedthrough the central opening of the plaque, according to an embodiment ofthe invention;

FIG. 22C illustrates the microcatheter of FIG. 22A and FIG. 22B fullydilated within the region of plaque, thus temporarily relieving therestriction caused by the plaque, according to an embodiment of theinvention;

FIG. 23A illustrates a length of vasculature having an aneurysm and apartially dislodged embolic coil projecting into the lumen of the parentvessel, wherein a microcatheter is being advanced toward the dislodgedcoil, according to an embodiment of the invention;

FIG. 23B illustrates an expandable region of the microcatheter in itsfully dilated configuration in the proximity of the aneurysm and thepartially dislodged coil, according to an embodiment of the invention;

FIG. 23C illustrates a grasper advanced through the central lumen of themicrocatheter, wherein the grasper is snaring an end of the dislodgedembolic coil, and further wherein an expandable tip guide catheter hasbeen advanced over the microcatheter to receive the snared coil;

FIG. 24A illustrates a microcatheter being advanced toward an emboliccoil which has become partially dislodged from an aneurysm, according toan embodiment of the invention;

FIG. 24B illustrates an expandable member of the microcatheter dilatedadjacent to the aneurysm such that the dislodged end of the coil hasbecome entrapped within the mesh of the expandable member, according toan embodiment of the invention;

FIG. 24C illustrates the expandable member having been constricted to areduced diametric dimension to secure the coil end within its structure,the expandable member being withdrawn proximally into a flared receivingcatheter, according to an embodiment of the invention;

FIG. 25A illustrates an expandable member dilated downstream of athrombus formation through which a microcatheter has been advanced,wherein a membrane partially covers the expandable member, according toan embodiment of the invention;

FIG. 25B illustrates an expandable member dilated downstream of athrombus formation wherein a membrane substantially seals the gaps inthe entire expandable member, according to an embodiment of theinvention;

FIG. 26 illustrates a partial breakaway view of the proximal end of anexpandable guide catheter, according to an embodiment of the invention;

FIG. 27A illustrates a longitudinal cross-section of the distal end ofan expandable guide catheter in its radially collapsed configuration,according to an embodiment of the invention;

FIG. 27B illustrates a partial breakaway view of the distal end of theexpandable guide catheter of FIG. 27A, wherein the distal end has beenradially expanded to a second, larger diameter or cross-section,according to an embodiment of the invention;

FIG. 28A illustrates a radially collapsed, expandable guide catheterbeing advanced toward a vascular occlusion, according to an embodimentof the invention;

FIG. 28B illustrates the expandable guide catheter of FIG. 28A followingradial expansion of the distal end and distal extension of a guidewire,according to an embodiment of the invention;

FIG. 29A illustrates a thrombectomy catheter advanced through theexpandable guide catheter and placed with its collapsed, distal endacross an occlusive thrombus; according to an embodiment of theinvention;

FIG. 29B illustrates the thrombectomy catheter of FIG. 29A with its meshor snare diametrically expanded at a point past the location of athrombus;

FIG. 29C illustrates the expanded thrombectomy catheter of FIG. 29Bwherein the thrombectomy catheter has been withdrawn proximally to causethe thrombus to be trapped within the expandable guide catheter;

FIG. 30 illustrates a region of cerebrovasculature with an expandableguide catheter inserted with its collapsed distal region traversing atortuous region and a guidewire extending distally thereof; according toan embodiment of the invention;

FIG. 31 illustrates the expandable guide catheter inserted into thecerebrovasculature in close proximity to an occlusive clot and itsdistal end diametrically expanded; according to an embodiment of theinvention;

FIG. 32 illustrates the expandable guide catheter of FIG. 31 with a clotretrieving microcatheter inserted therethrough and beyond a clot priorto expansion of a distal snare element, according to an embodiment ofthe invention;

FIG. 33A illustrates a breakaway side view of a vessel having a thrombusdisposed therein, wherein a temporary flow restoration catheter has beeninserted through the clot, according to an embodiment of the invention;

FIG. 33B illustrates a breakaway side view of the vessel of FIG. 33Awherein the temporary flow restoration catheter has expanded an elementwithin the clot to create a channel through which blood can flow,according to an embodiment of the invention;

FIG. 34A illustrates an unexpanded distal end of a thrombectomy or flowrestoration catheter that is activated by distal advancement of theproximal end of an expandable mesh, according to an embodiment of theinvention;

FIG. 34B illustrates an expanded distal end of a thrombectomy or flowrestoration catheter having been activated by distal advance of anannular sleeve surrounding a guidewire against a feature coupled to theproximal end of the mesh, according to an embodiment of the invention;

FIG. 34C illustrates an expanded distal end of a thrombectomy or flowrestoration catheter having been activated by distal advance of a largeguidewire against a feature coupled to the proximal end of the mesh,according to an embodiment of the invention;

FIG. 35A illustrates the proximal end of a thrombectomy or flowrestoration catheter comprising a hub, a strain relief, a catheter tube,and a guidewire, according to an embodiment of the invention;

FIG. 35B illustrates the proximal end of a thrombectomy or flowrestoration catheter comprising a sleeve for actuating the distalexpandable region and a displacement limiting member, according to anembodiment of the invention;

FIG. 36A illustrates the proximal end of a thrombectomy or flowrestoration catheter comprising a hub, a hemostasis valve, an injectionport for thrombolytic or other pharmacologic agents, and a controlmember for advancing or retracting an actuation sleeve, according to anembodiment of the invention;

FIG. 36B illustrates an actuation guidewire suitable for distal advanceof the proximal end of an expandable mesh, according to an embodiment ofthe invention;

FIG. 37A illustrates a thrombectomy or flow restoration cathetercomprising a radiopaque slider having increased length, according to anembodiment of the invention;

FIG. 37B illustrates the thrombectomy or flow restoration catheter ofFIG. 37A wherein the slider has been advanced distally to substantiallyclose the visual, or radiographic, gap between the slider and a forwardradiopaque marker, according to an embodiment of the invention;

FIG. 38 illustrates the thrombectomy or flow restoration catheterdeployed within a thrombus such that a mesh is asymmetrically expandedwithin the thrombus such that the catheter shaft resides closer to oneside of the mesh than the other, according to an embodiment of theinvention;

FIG. 39A illustrates an activation guidewire slidably disposed within acatheter and passing out through the distal end of a mesh, according toan embodiment of the invention;

FIG. 39B illustrates the activation guidewire of FIG. 39A having beenradially expanded such that it can exert distal force against a slidercoupled to the proximal end of the expandable mesh, according to anembodiment of the invention;

FIG. 40A illustrates a thrombectomy or flow restoration cathetercomprising a standard, small diameter guidewire deployed therethroughand further comprising a short, tubular mesh slider deployed distally toa window in the catheter tubing wall, wherein the slider comprises atail disposed proximally and affixed to a collar and the proximal end ofthe mesh through a window in the catheter tubing, according to anembodiment of the invention;

FIG. 40B illustrates the thrombectomy or flow restoration catheter ofFIG. 40A, comprising a standard, large diameter activation guidewire anda modified ring and tail slider for moving the proximal end of the mesh,wherein the activation guidewire has been advanced distally to expandthe mesh, according to an embodiment of the invention;

FIG. 41A illustrates the distal end of an expandable guide catheterfurther comprising a reinforcing backbone and rib structure, wherein theguide catheter is deployed inside a blood vessel with its distal endunexpanded, according to an embodiment of the invention;

FIG. 41B illustrates the expandable guide catheter of FIG. 41A with itsdistal end expanded inside the blood vessel, according to an embodimentof the invention;

FIG. 42A illustrates a region of a thrombectomy or flow restorationcatheter wherein the proximal end of the mesh is affixed to a hydraulicplunger annularly placed between the guidewire and the inside diameterof the catheter tubing, according to an embodiment of the invention;

FIG. 42B illustrates the thrombectomy or flow restoration catheter ofFIG. 42A wherein the annulus between the guidewire and the catheterinside diameter has been pressurized, forcing the hydraulic plunger toadvance distally and resulting in diametric expansion of an expandablemesh element, according to an embodiment of the invention;

FIG. 43 illustrates a thrombectomy or flow restoration catheter routedthrough a vascular obstruction and pressurized with radiopaque dye suchthat dye has exited into the vascular lumen distal to and proximal tothe obstruction to visually depict the extent of the obstruction,according to an embodiment of the invention;

FIG. 44A illustrates an expandable guide catheter or aspiration catheterthat includes friction reducing rails disposed on its interior,according to an embodiment of the invention;

FIG. 44B illustrates a translation dilator having a helical cut at itsdistal end, fine snake cuts in the region proximal to the helical cuts,more coarse snake cuts proximal to the fine snake cuts, and a proximalregion with no cuts or other penetrations, according to an embodiment ofthe invention;

FIG. 45A illustrates the distal end of an expandable therapeutic guidecatheter in its first, diametrically collapsed state, having an internaltranslation dilator and capable of directing blood flow through avascular obstruction, according to an embodiment of the invention;

FIG. 45B illustrates the therapeutic expandable guide catheter with itstranslation dilator having been advanced distally such that the distal,radially expandable catheter tube has become diametrically increased insize or cross-section, according to an embodiment of the invention;

FIG. 46A illustrates a vessel with an internal obstruction such as athrombus, atheroma, or foreign body;

FIG. 46B illustrates the therapeutic expandable guide catheter of FIG.45A having been advanced through the obstruction with the distal end ofthe expandable guide catheter exposed and unobstructed within the vessellumen distal to the obstruction, according to an embodiment of theinvention;

FIG. 46C illustrates the therapeutic guide catheter with the guidewirehaving been removed and the distal end expanded radially by distaladvancement of the translation dilator 4502 such that blood flow throughthe obstruction has been restored, according to an embodiment of theinvention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The inventions disclosed herein may be embodied in other specific formswithout departing from its spirit or essential characteristics. Thedescribed embodiments are to be considered in all respects only asillustrative and not restrictive. The scope of the inventions istherefore indicated by the appended claims rather than the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

As used herein, the terms proximal and distal refer to a direction or aposition along a longitudinal axis of a catheter or medical instrument.Proximal refers to the end of the catheter or medical instrument closerto the operator, while distal refers to the end of the catheter ormedical instrument closer to the patient. For example, a first point isproximal to a second point if it is closer to the operator end of thecatheter or medical instrument than the second point. The measurementterm French, abbreviated Fr or F, is defined as three times the diameterof a device as measured in mm. Thus, a 3 mm diameter catheter is 9French in diameter.

There is provided in accordance with one aspect of the presentinvention, a method for removing, or restoring flow through,thromboembolic material from a carotid or cerebral artery. The methodcomprises the steps of providing a catheter having a proximal end, adistal end, an expandable distal section having a distal port, anaspiration lumen communicating with the port, and an axially movablesupport. The distal end of the catheter is inserted into the artery, andthe support is distally advanced to expand the distal section. Negativepressure is applied to the aspiration port, to draw the thromboembolicmaterial into the distal section.

The carotid artery may be the common carotid artery, the internalcarotid artery or the carotid siphon. Alternatively, the artery may bethe middle cerebral artery or the anterior cerebral artery, or elsewherein the brain.

The method may additionally comprise the steps of introducing oxygenatedmedium into the artery through the aspiration lumen, or infusingpharmaceutical agent into the artery through the aspiration lumen. Thepharmaceutical agent may be a vasodilator such as nifedipine ornitroprusside. The pharmaceutical agent may alternatively comprise t-PA.The thromboembolic material may be located using intravascularultrasound, or carotid Doppler imaging techniques.

In accordance with another aspect of the present invention, there isprovided an intracranial aspiration catheter. The catheter comprises anelongate flexible tubular body, having a proximal end, a distal end, andan aspiration lumen extending therethrough. The aspiration lumen in adistal section of the body is movable between a first, reduced insidediameter for transluminal navigation and a second, enlarged insidediameter for aspirating material. A support is provided, forcontrollably supporting the aspiration lumen against collapse when inthe second diameter. A control is provided on the proximal end of thecatheter for controlling the support. In one implementation, the supportcomprises a spiral element such as a spring coil. The support may beaxially movable, such as between a proximal position when the distalsection is in the low cross sectional configuration, and a distalposition in which the distal section is enlarged, and supported againstcollapse under aspiration. Alternatively, the support is activated byrotating a first end of the support relative to a second end of thesupport.

The aspiration lumen may be defined within a tubular wall having aplurality of folds therein, when the aspiration lumen is in the firstinside diameter configuration. Alternatively, the aspiration lumen maybe defined within a wall made from a stretchable material.

In accordance with another aspect of the present invention, there isprovided a method of establishing a flow path through a catheter,positioned across a non-linear segment of vasculature. The methodcomprises the steps of transluminally navigating an enlargeable tubularwall through a non-linear segment of vasculature, and manipulating asupport within a tubular wall to enlarge the inside diameter of thetubular wall to create a flow path across the non-linear segment. Themanipulating step may comprise distally advancing a tubular supportstructure within the tubular wall. In one implementation, the methodcomprises distally advancing a coil within the tubular wall.

In accordance with a further aspect of the present invention, there isprovided a method of aspirating material. The method comprises the stepsof transluminally advancing a catheter to the site of an obstruction,the catheter having an aspiration lumen therein. A support is movedwithin the aspiration lumen, and, thereafter, material is aspirated fromthe obstruction through the aspiration lumen.

In accordance with another aspect of the present invention, there isprovided an intracranial aspiration catheter. The catheter comprises anelongate flexible tubular body, having a proximal end, a distal end, andan aspiration lumen extending therethrough. The distal section on thebody is movable between a first, reduced inside diameter fortransluminal navigation, and a second, enlarged inside diameter foraspirating material. A support is axially movable between a proximalposition when the aspiration lumen is in the first diameter, and adistal position for supporting the aspiration lumen against collapsewhen in the second diameter.

In one implementation, the support comprises a coil. The distal sectionmay have a length of no greater than about 20 cm, in certain embodimentsa length of no greater than about 10 cm, and often within the range offrom about 5 cm to about 15 cm.

In some embodiments, the intracranial aspiration catheter comprisesrails to reduce the friction between the support and the flexibletubular body. The rails comprise a plurality of longitudinally orientedstructures separated from each other by spaces, discontinuities, orgaps. The rails can be described as fingers, slats, battens, or thelike. The rails can be flexible and capable of bending. The rails can behighly lubricious such that they slide relative to the flexible tubularbody, the support, or both. The rails can be fabricated from metal,polymeric materials, or both. The metal can comprise materials such as,but not limited to, stainless steel, nickel titanium alloy, cobaltnickel alloy, titanium, tantalum, platinum, gold, or the like. Thepolymeric materials can comprise polyimide, polyamide, PTFE, PEN, PET,FEP, PFA, polyethylene, polypropylene, or the like. In some embodiments,the rails can be affixed, or integral to, the distal end of a hollowcylindrical pusher or support.

The proximal end of the support can be affixed to a hub or othermechanism that can be advanced or retracted by control of an operator atthe proximal end of the intracranial aspiration catheter. In otherembodiments, the rails can be affixed, or integral to, the interior ofthe flexible tubular body, especially within the expandable distalportion thereof. In a typical 5-French to 7-French catheter, the railscan comprise a cross-section that is roughly rectangular and havedimensions approximating 0.00025 to 0.001 inches in the radial directionand 0.002 to 0.03 inches in the circumferential direction. When thesupport is advanced distally to open the radially collapsed distal endof the flexible tubular body, the rails reduce or minimize the frictionbetween the support and the flexible tubular body. Separations betweenthe fingers of the rails permit flexibility for each rail and for thedistal end of the device, in general. The fingers, or rails, canbeneficially comprise very hard, very smooth surfaces that minimizedepressions or notches that could hinder movement of the slider. Thefingers or rails can beneficially be distributed within thecircumference of the flexible tubular body such that the support doesnot catch, snag, or drag on the interior of the flexible tubular body.

In a preferred embodiment, the distal end of the support, or dilator,can be an axially elongate tubular structure having a very thin wall,approximating 0.00025 inches to 0.010 inches. In a more preferredembodiment, the wall thickness ranges between about 0.001 and 0.005inches. The distal end of the dilator or support can have a rounded orfilleted profile to minimize the risk of snagging on the flexibletubular body, especially when the support is being advanced distallythrough a tortuous or highly curved region of the flexible tubular body.In certain preferred embodiments, the distal about 5 to 30 cm of theslider is spiral cut with the cuts penetrating completely through thewall of the slider. The region 5 to 30 cm immediately proximal to thespiral cuts can be snake cut to permit flexibility. The snake cuts canbe configured with increasing spaces (e.g. coarser construction) betweenthe cuts moving proximally to decrease flexibility of the system in themore proximal regions.

The support, or translation dilator, can comprise an inner structure of,for example, superelastic nitinol with an outer layer or coating offluoropolymer such as, but not limited to, PTFE, FEP, PFA, and the like.The fluoropolymer layer, preferably coated on the exterior of the innerstructure can have a thickness ranging between 0.0002 to 0.005 inches.The translation dilator can further comprise other lubricious coatingson its exterior. Such lubricious coatings can include polyurethane-basedhydrophilic coatings, silicone coatings, and the like.

In other embodiments, a microcatheter is disclosed, having an outsidediameter of approximately 3-French or smaller, with the incorporation ofan outer, diametrically expansile/contractile element or snare near thedistal region of the device. This expansile/contractile element coupledwith the micro-catheter system can serve a variety of therapeuticindications within the cerebrovasculature. Herein, the system may bedefined as a multi-utilitarian microcatheter. Included amongst theseindications are flow restoration within occluded vasculature or ducts,thrombus retrieval, thrombolysis, and temporary neck bridging/neckremodeling of aneurysms. In some embodiments, the microcatheter cancomprise a distention means for vascular anastomotic regions, flowrestoration within an occluded vessel, foreign body retrieval, or anendovascular filter.

In an embodiment, the micro-catheter can comprise means to delivertherapeutic devices and diagnostic agents through one or more of thecatheter's lumens or side holes, which further adds to this systemsutility. The devices' lumen, or lumens, could allow for aspiration ordrainage.

The Multi-Utilitarian Micro-Catheter System can be provided as anaxially elongate tubular structure with distal and proximal ends and alumen throughout its length. The length of the catheter can beapproximately 150 cm and can range between 100 cm and 200 cm. Thecatheter can have an outer diameter with the element contracted of nomore than 1 mm (3F). The micro-catheter advantageously comprises lateralflexibility, which can be constant or can comprise a plurality ofincreasingly flexible regions moving from the proximal to the distal endof the micro-catheter. The micro-catheter advantageously comprises theproperty of substantial column strength to facilitate pushabilitythrough the vasculature.

The outer diametrically expansile/contractile element, hereafterreferred to as the expandable element, which can be generally affixed tothe catheter shaft near the distal end of the micro-catheter shaft, canbe fabricated from a variety of metallic or polymeric materials, eitherporous, non-porous, or a combination of these materials. This expandableelement can be located proximate the distal region of themicro-catheter. In other embodiments, the expandable element or snarecan be located about 3-5 cm from the distal tip to improveguidewire-aided navigation through tortuous vasculature. The design isprovided with the expandable element having a maximum, expanded outerdiameter of 2 mm to 10 mm, but preferably between 2 mm to 7 mm. Theexpandable element outer diameter can range between 0.2 mm to 10 mmlarger in diameter than the outer diameter of the micro-catheter shaft.

To contract the expandable element diametrically, a standard 0.010″,0.013″ diameter guidewire, or other appropriate size, is introduced withthe catheter's lumen and one or more lumen constrictions are providedjust distal to the expandable element, with an optional constrictionpositioned proximal to the expandable element. Once the guidewire ispositioned through these constrictions, it provides enough frictionallyinduced axial force on the distal constriction to cause the expandableelement to contract in diameter (and expand the element linearly). Theguidewire can also increase the bending stiffness of the cathetersystem. The proximal constriction is useful in maintaining guidewireposition and can be advantageous if the guidewire is not otherwisesecured at the proximal end of the catheter system. The distal lumenwithin the element can be provided with a length of helically disposedtubing, a length of serpentine tubing, a biased coil having a centrallumen through which a secondary catheter can be inserted, a telescopingtube set, or a bellows mechanism, which provides a corresponding lengthalteration of the catheter's lumen to coincide with that of theexpandable element. The length of the expandable element can be between10 mm and 50 mm in the outer diametrically expansile configuration andbetween 12 mm and 100 mm in length in its contractile, minimum diameterconfiguration.

In other embodiments, the guidewire can straighten a pre-curved cathetershaft disposed between the two ends of an expandable snare or element.Straightening of the pre-curved catheter shaft can result in the twoends of the expandable element being moved axially apart causing theexpandable snare or element to diametrically collapse to a first,diametrically unexpanded configuration. Removing the guidewire can causethe pre-curved catheter shaft to restore to its original curved orserpentine shape, decreasing the distance between the two ends of anexpandable snare or mesh, and causing the snare or mesh to increase indiameter to a second, diametrically expanded configuration.

Another aspect or embodiment of the invention comprises a radially, ordiametrically, expandable or contractible flow restoration, foreign bodyretrieval, or thrombus retrieval element that is expanded by coercingthe proximal end of the element to advance distally, relative to astationary distal end of the element. Distal advance of the proximalportion of the element is slidably constrained about the outer diameterof the catheter shaft. A guidewire, sleeve, step guidewire, linkage,pusher, or other element can be inserted from the proximal end of thecatheter, through a central lumen of the catheter and force an internaltraveler, slider, or gate to advance distally. The traveler can beaffixed to an external collar through a window or skive in the cathetershaft, causing the external collar, to which the proximal end of theelement is affixed, to move distally, resulting in diametric, lateral,or radial, expansion of the element.

Other aspects or embodiments of the inventions include the methods ofuse. In a first embodiment, the device can be used for the purposes ofthrombus engagement, thrombus manipulation, and flow restoration withina partially or totally occluded vessel. In this embodiment, the deviceis first prepared by flushing, or priming, the lumen with saline. A0.010″ OD guidewire is then placed within the lumen to contract, inwardsor downwards, the outer diameter of the expandable element. The system(catheter and guidewire) is then navigated together to the site of theocclusive thrombus. The catheter and guidewire are advanced through thethrombus so that the expandable element is positioned within thethrombus. Once positioned through the thrombus, the guidewire is thenremoved (or partially pulled back away for the lumen constrictions).This allows for the element to expand within the thrombus accomplishingtwo purposes; 1) to entwine the thrombus, pushing it outwardly againstthe vessel wall, and 2) to allow blood flow restoration to occur toischemic areas distal of the thrombus, either acutely or extendedperiods of time. Additionally, diagnostic agents (such as radiographic,MRI, or other contrast agents) can be administered through the catheterlumen to assess the vasculature distal to the occlusive thrombus.

In another embodiment of the methods of use, the catheter can be used toperform targeted thrombolysis. In this embodiment, the device is firstprepared by flushing or priming the lumen with saline. A 0.010″ OD, orother size, guidewire can then be inserted within the lumen to contract,inwards or downwards, the outer diameter of the element. The system(catheter and guidewire) are then navigated together to the site of theocclusive thrombus. The catheter and guidewire are advanced through thethrombus so that the expandable element is positioned within thethrombus. Once the element is expanded, the thrombus is immobilized.Thrombolytic agents, or other therapeutic agents, can be administereddirectly into the thrombus through side holes located in the wall of thecatheter in the region of the expandable element. The side holesoperably communicate between the lumen of the catheter and theenvironment outside the catheter.

In another embodiment of the methods of use, the catheter can be used toperform thrombus retrieval. In this embodiment, the device is firstprepared by flushing or priming the lumen with saline. A 0.010″ ODguidewire is then inserted within the lumen to contract, inwards ordownwards, the outer diameter of the element. The system is thennavigated together to the site of the occlusive thrombus. The catheterand guidewire are advanced through the thrombus so that the expandableelement is positioned within the thrombus. The expandable element isexpanded, engaging the thrombus. After engaging the thrombus with theexpanded element, the user can either administer thrombolytic agents,contract the element by moving forward the guidewire through theconstrictions, or both, to further entwine the thrombus. The catheterwith entrapped thrombus is then removed from the vasculature.Additionally, the user may elect to keep the element expanded, andremove the catheter device from the vasculature. Lastly, the thrombusremoval could be aided by aspiration through the catheter side holes.

In another embodiment of the methods of use, the catheter can be used toperform temporary neck remodeling of aneurysms or other vascularlesions. Often during coil embolization of aneurysms, the aneurismalnecks encountered are considered wide, necessitating the need for aneck-bridging device such as a temporary micro-balloon or an implantablestent. These neck-bridging devices hold the coils in place to preventthem from dropping into the parent vessel during delivery. Balloonsconform to the inner surface of the vessel wall and provide a smoothsurface against the coils, but seal the vessel from blood flow forperhaps long durations, such sealing having potentially catastrophicischemic consequences if sustained for too long a time. After fillingthe aneurysm with coils these micro-balloons are deflated and removedfor the vasculature. Neurological stents are permanent implants that canbridge the neck during the coiling procedure, they are expensive andnon-retrievable, but allow blood flow through them. The design/methodconcept disclosed herein would be to employ the microcatheter with theexpandable element positioned across the neck of the aneurysm andradially expand the element to provide the neck bridge. The element inthis case could be provided with a non-porous surface about thecylindrical outer surface portion enabling a smoother, non-open surfaceagainst the delivered embolization coils. Other embodiments can comprisea window, a skive, a hole, or a breach in the medial or distal portionof the catheter to allow the introduction of a coil delivermicro-catheter (coaxially) into the aneurysm. In this embodiment, thecatheter system may be slightly larger (3-Fr to 5-Fr) than the up to3-Fr diameter typical microcatheter.

In other embodiments, the microcatheter can be used for the purposes ofanastomosis distension or dilation, vascular foreign body retrieval,temporary dilatation and flow restoration through atheromatous plaque,and vascular embolic filtering. These goals can be addressed byinserting the proper therapeutic device, such as a dilatation balloon,grasper or basket device, high force mesh dilator, or distal protectionfilter, respectively, through the working lumen of the microcatheter.

In certain embodiments, the expandable aspiration catheter can serve asan expandable guide catheter for placement of the micro-catheter. Theexpandable guide catheter is advanced to a target region in cooperationwith a guidewire to allow for steering and manipulation through thevasculature. In an exemplary procedure, the guidewire and expandableguide catheter are introduced into the vasculature at a site within afemoral or iliac artery. Using a Seldinger technique, or otherpercutaneous procedure, a hollow 18-Gauge needle can be introduced intoa femoral artery via percutaneous procedure. A guidewire is nextadvanced through the hollow needle and into the arterial tree. Thehollow needle is next removed and a catheter introducer is advanced intothe arterial tree. The expandable guide catheter is next advancedthrough the catheter introducer either through the same guidewire orthrough a larger guidewire suitable for aortic traverse. The expandableguide catheter, in its radially collapsed configuration, is advancedthrough the aortic arch, into a carotid artery, through the carotidsiphon and into a region proximate the circle of Willis. The distal endof the expandable guide catheter is next expanded by advancing aninternal element distally to force the distal end radially outward andmaintain an enlarged diameter inner lumen. The expandable guide cathetercan provide a very small diameter, flexible catheter that is easilyinserted through tortuous anatomy such as the carotid siphon or thevertebral and basilar arteries. Once properly placed, the expandableguide catheter can be diametrically expanded to generate a lumen largerthan would be possible with a standard, non-expandable catheter. Inaddition, the expanded guide catheter can partially or completelystraighten out the tortuous vasculature to allow passage of largerdiameter, less flexible microcatheters suitable for advanced therapeuticor diagnostic purposes. The expanded guide catheter can serve as anaspiration device and as a shield for retrieval of debris, thrombus, orother material from the vasculature.

For purposes of summarizing the invention, certain aspects, advantagesand novel features of the invention are described herein. It is to beunderstood that not necessarily all such advantages may be achieved inaccordance with any particular embodiment of the invention. Thus, forexample, those skilled in the art will recognize that the invention maybe embodied or carried out in a manner that achieves one advantage orgroup of advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein. These and other objectsand advantages of the present invention will be more apparent from thefollowing description taken in conjunction with the accompanyingdrawings.

Referring to FIG. 1, there is disclosed a catheter 10 in accordance withone aspect of the present invention. Although primarily described in thecontext of a an expandable distal segment aspiration catheter with asingle central lumen, catheters of the present invention can readily bemodified to incorporate additional structures, such as permanent orremovable column strength enhancing mandrels, two or more lumen such asto permit drug or irrigant infusion or radiation delivery or to supplyinflation media to an inflatable balloon, or combinations of thesefeatures, as will be readily apparent to one of skill in the art in viewof the disclosure herein. In addition, the present invention will bedescribed primarily in the context of removing obstructive material fromremote vasculature in the brain.

The catheters disclosed herein may readily be adapted for use throughoutthe body wherever it may be desirable to introduce a low profilecatheter and then provided a relatively large diameter aspiration orsupported working channel. For example, low diameter catheter shafts inaccordance with the present invention may be dimensioned for usethroughout the coronary and peripheral vasculature, the gastrointestinaltract, the urethra, ureters, Fallopian tubes and other lumens andpotential lumens, as well. The expandable lumen structure of the presentinvention may also be used as a minimally invasive percutaneous tissuetract expander, such as for diagnostic or therapeutic access to a solidtissue target (e.g., breast biopsy or tissue excision).

The catheter 10 generally comprises an elongate tubular body 16extending between a proximal end 12 and a distal functional end 14. Thelength of the tubular body 16 depends upon the desired application. Forexample, lengths in the area of from about 120 cm to about 140 cm ormore are typical for use in femoral access percutaneous transluminalcoronary applications. Intracranial or other applications may call for adifferent catheter shaft length depending upon the vascular access site,as will be understood in the art.

In the illustrated embodiment, the tubular body 16 is divided into atleast a fixed diameter proximal section 33 and an adjustable diameterdistal section 34 separated by a transition 32, discussed infra.Alternatively, the adjustable diameter feature of distal section 34 canextend the entire length of the catheter from the manifold 18 or otherproximal connector to distal tip 25, as will become apparent from thedisclosure herein.

The proximal end 12 of catheter 10 is additionally provided with amanifold 18 having one or more access ports as is known in the art.Generally, manifold 18 is provided with a guidewire port 20 in anover-the-wire construction, and an aspiration port 22. Alternatively,the aspiration port 22 may be omitted if the procedure involves removalof the guidewire proximally from the guidewire port 20 followingplacement of the aspiration catheter, and aspiration through theguidewire port. Additional access ports may be provided as needed,depending upon the functional capabilities of the catheter. Manifold 18may be injection molded from any of a variety of medical grade plastics,or formed in accordance with other techniques known in the art.

Manifold 18 is additionally provided with a control 24, for controllingthe radial expansion of the distal segment 34 of the catheter. Control24 may take any of a variety of forms depending upon the mechanicalstructure of the support. In the illustrated embodiment, control 24comprises a slider switch, which is mechanically axially moveably linkedto the distal support (discussed below) such that proximal retraction ofthe slider switch 24 produces a proximal movement of the support. Thisallows the unsupported distal section 34 to assume its low profileconfiguration as illustrated in FIG. 1. Distal axial advancement of theslider switch 24 produces a distal axial advance of the support, asillustrated in FIG. 2. In the distal position, the support advances thedistal segment 34 from the reduced diameter as illustrated in FIG. 1, tothe enlarged diameter as illustrated in FIG. 2. In the enlargedconfiguration, the support maintains patency of a central lumenextending through the distal segment 34 to accommodate aspiration aswill be discussed below.

Any of a variety of controls may be utilized, including switches,levers, rotatable knobs, pull/push wires, and others, which will beapparent to those of skill in the art in view of the disclosure herein.

Referring to FIG. 3A, there is illustrated a cross-sectional viewthrough the proximal section 33 of the catheter shaft 16 of theembodiment of FIG. 1. In the illustrated embodiment, the proximalsection 33 comprises a two lumen extrusion, having a control wire lumen30 with an axially movable control wire 32 therein, and an aspirationlumen 38. Aspiration lumen 38 also can serve as the guidewire lumen.Alternatively, the proximal section 33 can be formed having a concentricconfiguration if desired.

In an alternate configuration, as illustrated in FIG. 3B, a three lumenextrusion is utilized in the proximal section 33. A separate guidewirelumen 28 is provided, for allowing an over-the-wire configuration inwhich the guidewire does not need to be removed in order to accomplishaspiration. The guidewire lumen 28 therefore extends between a proximalaccess port 20 on the manifold 18, and a distal internal access port(not illustrated) at which point the guidewire lumen 28 opens distallyinto the aspiration lumen 38. Generally, the distal access port will bespaced substantially distally from the manifold along the length of thecatheter. The distal access port may be positioned anywhere within therange of from about 10 cm to about 60 cm from the distal end of thecatheter. This enables a partial proximal withdrawal of the guidewirefollowing placement of the catheter, to allow use of the aspirationlumen 38 as will be apparent to those of skill in the art. However, theguidewire may remain within the guidewire lumen 28, such that it can bereadily distally advanced into the distal vasculature, such as forrepositioning or replacement of the catheter 10.

The distal section 34 comprises a thin flexible wall defining a centrallumen 38 extending axially therethrough. The flexible wall is capable ofmoving between a reduced crossing profile configuration, such as thatillustrated in FIG. 1, and an enlarged crossing profile configurationsuch as that illustrated in FIG. 2. The reduced crossing profileconfiguration of FIG. 1 is provided for transluminal navigation ofdistal torturous vasculature to reach a target site. Once the targetsite has been reached, the distal segment 34 is radially enlarged andsupported to provide an enlarged working channel such as an aspirationlumen as will be discussed below.

Movement of the distal section 34 from the reduced diameter to theenlarged diameter may be accomplished in a variety of ways, dependingupon the desired construction. Referring to FIG. 4A, for example, a thinwalled tubular segment is provided having an enlarged diameter, such asequivalent to the enlarged diameter of FIG. 2. The tubular segment isfolded such as by partially collapsing a first wing 42 and a second wing44, leaving a reduced diameter central lumen 38 having a sufficientinside diameter to axially advance over a guidewire. The first andsecond wings 42 and 44 are thereafter wrapped around a central portion46 of the distal section 34 as illustrated in FIG. 4A. The resultingfolded configuration may be retained by applying a heat set, as is knownin the balloon angioplasty arts. The distal section 34 may be attachedin the vicinity of transition 32 using well known catheter fabricationtechniques.

In general, the collapsed diameter of lumen 38 will be approximately0.003 inches or greater larger than the outside diameter of the intendedguidewire. Guidewires having diameters in the range of from about 0.009inches to about 0.016 inches are presently contemplated.

Avoiding a tight fit between the guidewire 40 and the inside diameter ofthe guidewire lumen 28 enhances the slideability of the catheter overthe guidewire. In ultra small diameter catheter designs, it may bedesirable to coat the outside surface of the guidewire 40 and/or theinside surface of the wall defining lumen 38 with a lubricous coating tominimize friction as the catheter 10 is axially moved with respect tothe guidewire 40. A variety of coatings may be utilized, such asParylene, Teflon, silicone rubber, polyimide-polytetrafluoroethylenecomposite materials or others known in the art and suitable dependingupon the material of the guidewire or inner tubular wall 38.

In an alternate configuration, as illustrated in FIG. 4B, the tubularwall 40 is provided with a plurality of wings 46. Each of these may befolded and provided with a heat set to produce a reduced diameterconfiguration. Alternatively, the tubular wall 40 may be extruded in thewinged configuration, depending upon the desired manufacturingtechnique.

Referring to FIGS. 5 and 6, a movable support 50 is provided forenlarging the distal section 34 from the reduced diameter to theenlarged diameter configuration. In the illustrated embodiment, themovable support 50 is in the form of an axially movable coil 52. Coil 52is mechanically linked to the control 24 by an axially movable controlwire 32. Distal advance of the control 24 causes the control wire 32 toadvance distally through the control wire lumen 30, thereby advancingthe movable coil 52 from a position within the proximal section 33,across the transition 32 and into the distal section 38. This causes thedistal section 34 to move from the reduced diameter to the enlargeddiameter configuration.

The coil 52 resists collapse of the tubular wall 40 when vacuum isapplied to the central lumen 38. Due to the radial supportcharacteristics of the movable coil 52, the wall thickness of thetubular wall 40 may be minimized to a limit which is determined byphysical characteristics of the polymer, together with the spacingbetween adjacent filars of the movable coil 52. Optimal relationshipsbetween these variables can be determined through routineexperimentation by those of ordinary skill in the art, in view of thedisclosure herein.

The use of an axially movable coil 52 is believed to enable both radialenlargement of the distal aspiration lumen 38, as well as placement of alarge ID aspiration lumen in small vessels, even around corners in thevasculature. The catheter can be placed within torturous vasculaturewhile in the low profile configuration, to reach a remote site. Distaladvance of the support coil within the catheter can then track throughthe tortuous vasculature while radially enlarging the aspiration lumen.This is enabled through the use of a laterally flexible tubular support,such as a helix, spring, micro slotted tube or other tubular supportwith lateral flexibility. In this manner, the distal section 34 may bepositioned within portions of the anatomy and then enlarged to adiameter, which would not have been able to axially traverse thevasculature without unacceptable levels of vascular trauma, usingconventional catheter constructions.

The exact configuration of the moveable support 50 may be variedconsiderably, and still accomplish the objectives of the presentinvention. For example, referring to FIGS. 7 and 8, the moveable support50 is in the form of a helical ribbon 54. The helical ribbon 54 may beprovided by helically cutting through the wall of a segment of thedistal end of a tube 56 using techniques, which are disclosed elsewhereherein. Thus, as illustrated in FIG. 8, a support zone 58 is provided onthe distal end of a tube 56. Tube 56 may extend concentrically withinthe central lumen 38 proximally to the manifold 18, or to a control onthe proximal catheter shaft. Alternatively, 256 may be in mechanicalcommunication with the control 24 by way of an axially moveable controlwire 32 as has been discussed. Ribbon 54 may alternatively be formed bywrapping around a mandrel, or other techniques which will be known tothose of skill in the art.

Aspiration catheters of the present invention, which are adapted forintracranial applications, generally have a total length in the range offrom 60 cm to 250 cm, usually from about 135 cm to about 175 cm. Thelength of the proximal segment 33 will typically be from 20 cm to 220cm, more typically from 100 cm to about 120 cm. The length of the distalsegment 34 will typically be in the range from 2 cm to about 50 cm,usually from about 5 cm to about 20 cm. The proximal and distal bodysegments 33, 34 may be joined to each other, i.e. at a transition 32.The body segments may be joined in any of a variety of conventionalmanners, such as heat fusion, adhesive bonding, co-extrusion, or thelike. In the exemplary embodiment, the two body segments 33, 34 will beformed separately and thereafter fused together by the application ofheat with a removable mandrel extending through each lumen, whichcrosses the transition 32 to maintain patency. A length of outershrink-wrap tubing may be used to add structural integrity by spanningthe transition 32.

The catheters of the present invention may be composed of any of avariety of biologically compatible polymeric resins having suitablecharacteristics when formed into the tubular catheter body segments.Exemplary materials include polyvinyl chloride, polyethers, polyamides,polyethylenes, polyurethanes, copolymers thereof, and the like. Incertain embodiments, in which the distal segment 34 dilates (stretches)radially rather than unfolds, the distal segment 34 may be formed frommore elastic materials, such as latex rubber, silicone rubber, andblends thereof. In one embodiment, both the proximal body segment 33 anddistal body segment 34 will comprise a polyvinyl chloride (PVC), withthe proximal body segment being formed from a relatively rigid PVC andthe distal body segment being formed from a relatively flexible, supplePVC. Optionally, the proximal body segment may be reinforced with ametal or polymeric braid or other conventional reinforcing layer.

The proximal body segment will exhibit sufficient column strength topermit axial positioning of the catheter through a guide catheter atleast a portion of with the distal body segment 34 extending into thepatient's vasculature. The proximal body segment may have shore hardnessin the range from 50 D to 100 D, often being about 70 D to 80 D.Usually, the proximal shaft will have a flexural modulus from 20,000 psito 1,000,000 psi, preferably from 100,000 psi to 600,000 psi. The distalbody segment will be sufficiently flexible and supple so that it maynavigate the patient's distal vasculature. In highly flexibleembodiments, the shore hardness of the distal body segment 34 may be inthe range of from about 20 A to about 100 A, and the flexural modulusfor the distal segment 34 may be from about 50 psi to about 15,000 psi.

The catheter body may further comprise other components, such asradiopaque fillers; colorants; reinforcing materials; reinforcementlayers, such as braids and helical reinforcement elements; or the like.In particular, the proximal body segment may be reinforced in order toenhance its column strength and torqueability while preferably limitingits wall thickness and outside diameter.

The pleated or otherwise reduced diameter of the distal body segment 34will usually be smaller than that of the proximal body segment. In someintracranial applications, the proximal body segment will have aconstant diameter, with an outer diameter in the range from 0.33 mm to 2mm, usually from 0.67 mm to 1.67 mm, and an inner diameter in the rangefrom 0.1 mm to 1.75 mm, usually from 0.2 mm to 1 mm. The distal bodysegment can be tapered, where its proximal end has a diameter, whichgenerally is the same as that of the distal end of the proximal bodysegment and its distal end has a diameter no greater than the range setforth above.

Usually, radiopaque markers will be provided at least at the distal end25 and the transition region 32 between the proximal and distal bodysegments 33, 34. Other radiopaque markers may be provided elsewhere,such as on the support coil, if it is not already radiopaque. Oneradiopaque marker comprises a metal band, which is fully recessed withinthe distal end of the proximal body segment 33. Suitable marker bandscan be produced from a variety of materials, including platinum, gold,and tungsten/rhenium alloy. Preferably, the radiopaque metal band willbe recessed in an annular channel formed at the distal end of theproximal body segment.

The proximal section 33 of tubular body 16 may be produced in accordancewith any of a variety of known techniques for manufacturinginterventional catheter bodies, such as by extrusion of appropriatebiocompatible polymeric materials. Alternatively, at least a proximalportion or all of the length of tubular body 16 may comprise a polymericor metal spring coil, solid walled hypodermic needle tubing, or braidedreinforced wall, as is known in the microcatheter arts.

In many applications, the proximal section 33 of tubular body 16 isprovided with an approximately circular cross-sectional configurationhaving an external diameter within the range of from about 0.025 inchesto about 0.065 inches. In accordance with one embodiment of theinvention, the proximal section 33 of tubular body 16 has an externaldiameter of about 0.042 inches (3.2 f) throughout most of its length.Alternatively, a generally oval or triangular cross-sectionalconfiguration can also be used, as well as other noncircularconfigurations, depending upon the method of manufacture, number andarrangement of internal lumens and the intended use.

In a catheter intended for peripheral vascular applications, theproximal section 33 of body 16 will typically have an outside diameterwithin the range of from about 0.039 inches to about 0.065 inches. Incoronary vascular applications, the proximal section 33 of body 16 willtypically have an outside diameter within the range of from about 0.025inches to about 0.045 inches. The illustrated construction of distalsection 34 permits lower external cross-sections in the collapsedconfiguration, as low as 0.028 inches or 0.025 inches or 0.022 inches orlower as may be desired for remote coronary or intracranialapplications.

Diameters outside of the preferred ranges may also be used, providedthat the functional consequences of the diameter are acceptable for theintended purpose of the catheter. For example, the lower limit of thediameter for any portion of tubular body 16 in a given application willbe a function of the number of fluid or other functional lumen containedin the catheter, together with the acceptable minimum aspiration flowrate and collapse resistance.

Tubular body 16 must have sufficient structural integrity (e.g., columnstrength or “pushability”) to permit the catheter to be advanced todistal locations without buckling or undesirable bending of the tubularbody. The ability of the body 16 to transmit torque may also bedesirable, such as to avoid kinking upon rotation, to assist insteering. The tubular body 16, and particularly the distal section 34,may be provided with any of a variety of torque and/or column strengthenhancing structures. For example, axially extending stiffening wires,spiral wrapped support layers, braided or woven reinforcement filamentsmay be built into or layered on the tubular body 16. See, for example,U.S. Pat. No. 5,891,114 to Chien, et al., the disclosure of which isincorporated in its entirety herein by reference.

In many applications, the proximal section 33 will not be required totraverse particularly low profile or tortuous arteries. For coronaryvascular applications, for example, the proximal section 33 will bemostly or entirely within the relatively large diameter guide catheter.The transition 32 can be located on the catheter shaft 16 to correspondapproximately with the distal end of the guide catheter when the balloon24 and/or distal end 14 is at the treatment site. Viewed the other way,the length of the distal section 34 is preferably at least as long asthe distance from the ostium of the relevant coronary artery to thetreatment site. In most applications, the transition 32 will be at leastabout 3 cm, preferably at least about 5 cm and alternatively as much asabout 10 cm but often not more than about 20 cm from the distal end ofthe catheter. Distances as much as 30 cm to 50 cm or greater between thetransition 32 and distal end of the catheter may also be desirable insome applications.

For certain other applications, such as intracranial catheterizations,the distal section 34 is preferably at least about 5 cm long and smallenough in diameter to pass through vessels as low as 3 mm or 2 mm orlower. Catheters for this application may have a proximal section lengthof between about 60 cm to about 150 cm and a distal section length ofbetween about 5 cm to about 15 cm, and the distal section is able totrack a tortuous path of at least about 5 cm through vessels of lessthan about 3 mm lumen ID. Further structure, dimensional and methoddisclosure can be found in U.S. Pat. No. 4,739,768 to Engelson, thedisclosure of which is incorporated in its entirety herein by reference.

The distal section 34, may be manufactured as an extrusion. In onemethod of manufacture, the extrusion is formed from a medium to highmelt index polyethylene or other polymer having an outside diameter ofgreater than the diameter of the desired finished product. The rawextrusion can thereafter be drawn down to the desired diameter, inaccordance with known processing techniques. The draw down pull speedcan be varied such as along a proximal portion of the extrusion toproduce a taper to a larger proximal diameter. This permits a smoothtransition 32 from the relatively smaller outside diameter distalsection 34 to the typically larger outside diameter of proximal section33. High melt index materials allow the production of a greater numberof different diameter draw downs by adjusting pull speed and otherprocess parameters, for a given set of tooling as will be appreciated bythose of skill in the art. The distal end 14 can be further reduced indiameter by an additional draw down step if desired.

Referring to FIGS. 7 and 8, the axially moveable support may be providedin the form of an elongate flexible tube 56. A distal section 58 oftubular element 56 is provided with a spiral cut, to retain radialstrength but provide lateral flexibility. The spiral cut section 58generally has a length within the range of from about 1 centimeter to 15centimeters, preferably within a range of about 5 centimeters to about12 centimeters, and, in a particular embodiment, extends forapproximately 10 centimeters in length. The spiral cut generally has apitch within the range of from about 0.01 inches to about 0.125 inches,and in one embodiment, has a 0.06 pitch. In another embodiment, thedistal section 58 comprises a first spiral cut section having a lengthof about 5 cm and a pitch of about 0.06, and a second, distal sectionhaving a length of about 5 cm and a pitch of about 0.030.

Preferably, the spiral cut extends completely through the wall of thetubular element 56 to produce a helical or coiled configuration. Theprecise pitch of the spiral cut and axial spacing of adjacent windingscan be varied widely while still accomplishing the purposes of thepresent invention, and can be optimized for any particular applicationin view of the disclosure herein.

For example, polytetrafluoroethylene tubing, such as that suitable fortubular element 56, can be commercially obtained from Zeus, inOrangeburg, S.C. The distal section 58 can be provided with a spiralcut, such as by any of a variety of techniques that can be devised bythose of skill in the art. In accordance with one technique, the PTFE orother tubing is placed onto a mandrel. The mandrel is attached to amachine with a predetermined screw thread. A cutting element such as arazor blade or other sharp instrument is placed across the tubing andthe machine is activated to rotate the mandrel. As rotation of themachine (screw thread) occurs, the mandrel moves axially androtationally causing the tubing to be cut in a spiral manner by thecutting implement. The machine can be set up to cut either a right orleft hand spiral. The machine can also be set to cut continuous orvariable pitch spirals, or multi-zone spiral sections in which each zonehas a unique pitch. A metal spring coil 54 can be wrapped about asuitably sized rotating mandrel as is known in the art, with the distalopen wound section 58 formed by stretching.

The tubular support 58 may alternatively be in the form of a wirespring, extending throughout the length of the distal segment or entirecatheter. See Generally FIGS. 5 and 6. A distal section 36 of the coilspring 52 is stretched axially to produce an open wound configuration,such that the axial space between adjacent windings of the coil may bewithin the range of from about 0.05 mm to about 1 mm or greater. Theproximal portion of coil spring 34 is generally bottomed out (notillustrated), such that adjacent windings of the coil are in contactwith one another. This provides column strength, to allow distaladvancement within the catheter, while retaining lateral flexibility.Alternatively, the coil spring can be open wound with, e.g., 0.01 mm to1 mm spacing for the entire length.

A variety of materials can be used to construct the coil spring 52, suchas stainless steel, platinum, platinum alloy, nickel, or titaniumalloys. Coil spring 52 can be produced from any of a variety of stockforms, such as round cross-sectional wire, square or other rectangularwire, or polymeric materials as are known in the art. In one embodiment,coil spring 52 is wound from a flat wire made from stainless steel andhaving cross-sectional dimensions of about 0.002 by about 0.006 inches.

The cerebral circulation is regulated in such a way that a constanttotal cerebral blood flow (CBF) is generally maintained under varyingconditions. For example, a reduction in flow to one part of the brain,such as in acute stroke, may be compensated by an increase in flow toanother part, so that CBF to any one region of the brain remainsunchanged. More importantly, when one part of the brain becomes ischemicdue to a vascular occlusion, the brain compensates by increasing bloodflow to the ischemic area through its collateral circulation.

FIG. 9 depicts a normal cerebral circulation and formation of Circle ofWillis. Aorta 100 gives rise to right brachiocephalic trunk 82, leftcommon carotid artery (CCA) 80, and left subclavian artery 84. Thebrachiocephalic artery further branches into right common carotid artery85 and right subclavian artery 83. The left CCA gives rise to leftinternal carotid artery (ICA) 90 which becomes left middle cerebralartery (MCA) 97 and left anterior cerebral artery (ACA) 99. Anteriorly,the Circle of Willis is formed by the internal carotid arteries, theanterior cerebral arteries, and anterior communicating artery 91 whichconnects the two ACAs. The right and left ICA also send right posteriorcommunicating artery 72 and left posterior communicating artery 95 toconnect, respectively, with right posterior cerebral artery (PCA) 74 andleft PCA 94. The two posterior communicating arteries and PCAs, and theorigin of the posterior cerebral artery from basilar artery 92 completethe circle posteriorly.

When an occlusion occurs acutely, for example, in left carotid siphon70, as depicted in FIG. 9, blood flow in the right cerebral arteries,left external carotid artery 78, right vertebral artery 76 and leftvertebral artery 77 increases, resulting in directional change of flowthrough the Circle of Willis to compensate for the sudden decrease ofblood flow in the left carotid siphon. Specifically, blood flow reversesin right posterior communicating artery 72, right PCA 74, left posteriorcommunicating artery 95. Anterior communicating artery 91 opens,reversing flow in left ACA 99, and flow increases in the left externalcarotid artery, reversing flow along left ophthalmic artery 75, all ofwhich contribute to flow in left ICA 90 distal the occlusion to provideperfusion to the ischemic area distal to the occlusion. A guidewire isillustrated in position proximal to the occlusion.

In use, the distal end of the aspiration catheter 10 is inserted throughan incision on a peripheral artery over the guidewire into a more distalcarotid or intracranial artery, such as the terminal ICA, carotidsiphon, MCA, or ACA. Thromboembolic material 202 is shown occluding thelumen of a cerebral artery narrowed by atheromatous plaque 200. Theocclusion site can be localized with cerebral angiogram or IVUS. Inemergency situations, the catheter can be inserted directly into thesymptomatic carotid artery after localization of the occlusion with theassistance of IVUS or standard carotid Doppler and TCD.

As illustrated in FIG. 10, the catheter 10 is transluminally navigatedalong or over the guidewire, to a position just proximal to theocclusion. Transluminal navigation is accomplished with the distalsection of the catheter in the first, reduced cross sectionalconfiguration. This enables navigation of tortuous vasculature which alarger cross section may not be able to traverse.

Referring to FIG. 11, the cross section of the distal segment isenlarged after the catheter has been positioned, such as by distallyaxially advancing a tubular support as has been described previously.This allows a larger inside diameter aspiration lumen than wouldotherwise have been navigable to the treatment site. In addition, theuse of a coil or spiral wrapping as the tubular support enables thedistal segment to be expanded through curves in the vasculature, withoutkinking or straightening the vasculature. As will be appreciated fromeven the simplified schematic of the cerebral vasculature shown in FIG.11, the length of the distal section may be varied depending upon theintended target site for the catheter. Since the inside diameter of thevasculature decreases distally, the length and collapsed crossingprofile of the distal section is designed to take into account thelength and inside diameter of the vessel leading up to a targetocclusion.

Aspiration is thereafter applied to the aspiration lumen, therebydrawing the occlusion into the catheter as illustrated in FIG. 12. Thedistal section may thereafter be reduced in cross section, and thecatheter proximally retracted from the patient. A vasodilator, e.g.,nifedipine or nitroprusside, may be injected through lumen 38 and port25 to reverse vascular spasm induced as a result of instrumentation.

Pressure may be monitored by a manometer and can be altered by applyingvacuum to the proximal end of the catheter. A pressure dial, which maybe included in the proximal end of the catheter, allows suction withinthe vessel to be regulated. When continuous negative pressure isapplied, occluding material 202 is dislodged into aspiration port 25 andproximally through aspiration lumen 38.

If the occlusion is not removed by the above continuous suction method,intermittent suction can be used to create an alternatingnegative-positive pressure gradient, which may dislodge thethromboembolic occlusion. Alternatively, a thrombolytic agent, e.g.,t-PA may be infused through lumen 38 and port 25 to lyse the occlusionif soft thrombus is suspected. Standard atherectomy or angioplasty withor without stent placement can also be performed on atheromatous plaqueafter removal of the occlusion if perfusion through the diseased arteryis still inadequate.

Focal hypothermia, which has been shown to be neuroprotective, can beadministered by perfusing hypothermic oxygenated blood or fluid.Perfusion through port 25 can be achieved by withdrawing venous bloodfrom a peripheral vein and processing through a pump oxygenator, or bywithdrawing oxygenated blood from a peripheral artery, such as a femoralartery, and pumping it back into the carotid artery.

If suction fails to dislodge the occlusion, a thrombolytic agent, e.g.,t-PA, can be infused through lumen 38 and port 25 to lyse any thromboticmaterial with greater local efficacy and fewer systemic complications.Administration of thrombolytic agent, however, may not be recommendedfor devices, which are inserted directly into the carotid artery due toincreased risk of hemorrhage. If perfusion is continued for more than afew minutes, removal of excess fluid from the circulation is required toavoid fluid overload. Fluid can be withdrawn from a jugular vein or fromany other peripheral vein or artery, e.g., the femoral vein or artery,and re-introduced into the symptomatic artery. Moderate hypothermia, atapproximately 32 to 34 degrees Centigrade, can be introduced during thefluid recirculation.

In patients with vertebral artery occlusions, treatment with angioplastyoften results in disastrous complications due to embolization of theocclusive lesion downstream to the basilar artery. Emboli small enoughto pass through the vertebral arteries into the larger basilar arteryare usually arrested at the top of the basilar artery, where itbifurcates into the posterior cerebral arteries. The resulting reductionin blood flow to the ascending reticular formation of the midbrain andthalamus produces immediate loss of consciousness. The devices describedin FIG. 1 through FIG. 8 can be used to remove thromboembolic materialfrom the vertebral artery. The occlusion site is first localized withtranscranial Doppler and angiogram. The catheter 10 can be insertedthrough an incision on a peripheral artery into the symptomaticvertebral artery or the subclavian artery. For example, the distal endof catheter 10 may be inserted proximal to thromboembolic material 202in right vertebral artery 87 and left subclavian artery 84. Whencontinuous or intermittent suction is applied to the distal end of thecatheter, the pressure gradient across the occluding lesion increasesand thromboembolic material 202 may be dislodged and captured by theaspiration port. The thromboembolic material may thereafter be removedcontinuous or pulsed suction, thereby reducing the risk of embolizationto the basilar artery.

Access for the catheter of the present invention can be achieved usingconventional techniques through an incision on a peripheral artery, suchas right femoral artery, left femoral artery, right radial artery, leftradial artery, right brachial artery, left brachial artery, rightaxillary artery, left axillary artery, right subclavian artery, or leftsubclavian artery. An incision can also be made on right carotid arteryor left carotid artery 130 in emergency situations.

The length of the catheter for those access sites to reach the brainwill generally be between 20 to 100 centimeters, preferablyapproximately between 30 and 60 centimeters. The inner diameter of thecatheter may be between 0.2 and 0.6 centimeters, or smaller. Theforegoing ranges are set forth solely for the purpose of illustratingtypical device dimensions. The actual dimensions of a device constructedaccording to the principles of the present invention may obviously varyoutside of the listed ranges without departing from those basicprinciples.

FIG. 13A illustrates a microcatheter 100 comprising an outer shaft 102further comprising an outer shaft lumen 118, a hub 104 furthercomprising a proximal Luer lock adapter 120, a distal shaft 116 furthercomprising a distal shaft lumen 106, a distal constriction 108, aproximal constriction 128, and an expandable member 110 furthercomprising a proximal bond 114 and a distal bond 112. The expandablemember 110 is illustrated in its diametrically expanded configuration.

Referring to FIG. 13A, the proximal end of the outer shaft 102 isaffixed to the distal end of the hub 104. The inner lumen 118 of theouter shaft 102 is operably connected to the tapered lumen 130 of thehub 104 such that there are minimal or no bumps or obstructions topassage of catheters or guidewires from the tapered lumen 130 into theouter shaft inner lumen 118. The proximal end of the distal shaft 116 isslidably disposed within the distal end of the outer shaft 102. Theproximal end of the expandable member 110 is affixed to the outer shaft102 by the proximal bond 114. The distal end of the expandable member110 is affixed to the distal shaft 116 by the distal bond 112. Theexpandable member 110 retains a minimum and a maximum overall lengthbetween the distal bond 112 and the proximal bond 114 such that theoverlap distance between the two telescoping tubes 102 and 116 ismaintained to a minimum of about 1-cm. The distal constriction 108 isaffixed within the lumen 106 to the distal shaft 116. The distalconstriction 108 further comprises a central lumen (not shown) having anundeformed, or unstressed, diameter smaller than that of the guidewire124 meant to be inserted therethrough. The lumen diameter of the distalconstriction 108, or region of reduced diameter, can have a diameter ofbetween 100% and 10% of the guidewire 124, and preferably between 40%and 80% of that of the guidewire 124. The central lumen (not shown) ofthe distal constriction 108 can expand to accommodate insertion of theguidewire 124 but imparts substantial friction on the guidewire 124. Theproximal constriction 128 is affixed to the interior wall of the outershaft 102 and within the lumen 118. The proximal face of the proximalconstriction 128 can have an inwardly tapered funnel-like lead-in to thecentral lumen of the proximal constriction 128. This lead-in (not shown)can facilitate coercing the guidewire 124 into the central lumen of theproximal constriction 128. This is especially important in the largerdiameter inner lumen 118 of the outer shaft 102. The guidewire 124 canbe an elongate member configured to collapse/expand the expandablemember or region 110. The elongate member may also be a linkage,mechanical linkage, pushrod, push-pull rod, or the like. The guidewire124, or linkage, preferably comprises the properties of high columnstrength, high tensile strength, low elongation and high flexibility.

The hub 104 can be affixed to the outer shaft 102 by processes such as,but not limited to, adhesive bonding, heat welding, overmolding,insert-molding, ultrasonically welding, or the like. The proximal bond114 and the distal bond 112 can be created using processes such as, butnot limited to, adhesive bonding, heat welding, overmolding,insert-molding, ultrasonic welding, wrapping, mechanical fixation,encapsulation, and the like.

The overall working length of the microcatheter 100 can range betweenabout 50 cm and 200 cm with a preferred range of about 100 cm to 175 cm.The outside diameter of the outer shaft 102 can range between about 0.5French and 10 French with a preferred range of about 1-French to4-French. The length of the expandable member 110 in its radiallyexpanded configuration can range between about 1 cm and 20 cm with apreferred length range of about 2 cm and 10 cm and a most preferredrange of 2.5 cm to 5 cm. The length of the tapered regions at the end ofthe expandable member 110 can each range between about 5% and 40% of thetotal length of the expandable member 110. The expandable member 110 canhave an expanded diameter ranging from about 1-French to 13 French witha preferred diameter of about 2-French to 5 French. The diameter of theguidewire 124 can range between about 0.005 and 0.015 with a preferredrange of 0.008 to 0.012.

The materials appropriate to the construction of the microcatheter 100are biocompatible and sterilizable. The outer shaft 102 and the distalshaft 116 can be fabricated from relatively materials such as, but notlimited to, PTFE, Pebax, Hytrel, polyurethane, polyethylene, polyimide,polyamide, polyester, PEEK, and the like. The construction of the distalshaft 116 and the outer shaft 102 can be such that flexibility,torqueability, and column strength, all beneficial to a catheter, aremaintained. The distal shaft 116 and the outer shaft 102 can be ofsingular material construction or one or both can be of composite, orbuilt-up, construction. Such composite construction can comprise apolymeric inner and outer coat or surround enveloping a reinforcementlayer. The reinforcement layer can comprise braid, coil, or stent-shapedconstruction fabricated from materials such as, but not limited to,stainless steel, tantalum, titanium, nitinol, polyester, PEN, cobaltnickel alloy, polyamide, polyimide, and the like. The hub 104 can befabricated from more rigid materials such as, but not limited to,acrylonitrile butadiene styrene (ABS), polyethylene, polypropylene,polyamide, polyimide, polyether ether ketone (PEEK), polysulfone, andthe like. The mesh 110 can be fabricated from nitinol, stainless steel,titanium, cobalt nickel alloy, tantalum, polyimide, polyamide,polyester, and the like. In other embodiments, the outer shaft 102 canhave variable flexibility characteristics along its length. In certainembodiments, the outer shaft 102 can comprise continuously varyingproperties. In certain of the continuously varying property embodiments,the outer shaft 102 can be progressively more flexible moving from theproximal end toward the distal end. In certain embodiments, the outershaft 102 can comprise a plurality of regions of discreet flexibility.The number of regions of discreet flexibility can range between 2 and 10and preferably between 2 and 5. The regions closer to the distal end canbe made advantageously more flexible than regions closer to the proximalend of the outer shaft 102. Such changes in flexibility, for examplemoving from higher stiffness to lower stiffness, can be achieved bymethods such as, but not limited to, changing the polymer composition tolower hardness materials, changing the pitch of a coil reinforcement toprovide greater spacing between coils, changing the pitch of a braidedreinforcement to achieve greater spacing, changing the thickness of thewires used in a coil or braid to smaller dimensions, or the like.

The bars of the mesh 110 can comprise round, oval, rectangular, or othersuitable cross-sectional shape. The mesh 110 can also be configured as aslotted tube, or a plurality of bars oriented substantially parallel tothe longitudinal axis of the distal member 116. The mesh 110 can also beconfigured with all the patterns disclosed for various implantable stentdevices.

The overlap region between the distal shaft 116 and the outer shaft 102permits relative motion between the two shafts 116 and 102 while theexpandable member 110 changes its length in response to operatorcontrol. This length changing feature can also be accomplished byaffixing a helically disposed tube, a serpentine tube, a coil, a braidedtube, or other structure that can substantially maintain its shape butchange length in response to external forces to the outer shaft 102, thedistal shaft, 116, or both.

FIG. 13B illustrates the microcatheter 100 of FIG. 1A illustrated with aguidewire 124 inserted therethrough and the expandable member 110 in itsdiametrically constricted configuration. The microcatheter 100 comprisesthe hub 104, which is illustrated in cross-section, and furthercomprises a tapered lead in lumen 130. The microcatheter 100 furthercomprises the outer shaft 102, the outer shaft lumen 118, the distalshaft 116, the distal shaft lumen 106, the distal constriction 108, theproximal constriction, the distal bond 112, the proximal bond 114, theguidewire 124, and the guidewire proximal cap 126.

Referring to FIG. 13B, the guidewire 124 has been inserted through thelumen 130 of the hub 104 and into the lumen 118 of the outer shaft 102.The guidewire 124 is routed through the optional proximal constriction128, into the inner lumen 106 of the distal shaft 116, through thedistal constriction 108 and out the distal end of the inner lumen 106.It is also possible that the guidewire 124 will not pass entirelythrough the distal constriction 108, in which case, the guidewire 124would also not extend beyond the distal end of the inner lumen 106. Theguidewire proximal cap 126 is affixed to the proximal end of theguidewire 124. The guidewire proximal cap 126 is removably affixed tothe Luer lock fitting 120 on the hub 104. The guidewire 124 islongitudinally fixed relative to the inner shaft 118 and the distalconstriction 108 by locking the cap 126 to the hub 104. Distal motion ofthe guidewire 124 through the distal constriction 108 causes sufficientlongitudinal stretching force, due to application of friction by thedistal constriction 108, such that the expandable member 110 becomesstretched longitudinally to its maximum extent and thus the expandablemember 110 assumes its minimum radial dimension.

The proximal constriction 128 is optional but the friction supplied bythe proximal constriction 128 on the guidewire 124 can be used tostabilize the guidewire and maintain the expandable member 110 in itsfully stretched state without the need for the cap 126. Note that thedistal constriction 108 and the proximal constriction 128 are ofdifferent outside diameters to permit them to be affixed insidedifferent diameter tubes but the diameters of the constrictions 108 and128 can be tailored to the specific configuration of the catheter. Theconstrictions 108 and 128 can be of single material or multiple materiallayer construction. They can be fabricated from materials configured togenerate high friction such as, but not limited to, silicone elastomer,latex rubber, thermoplastic elastomer, polyurethane, and the like. Theseelastomeric materials can be fabricated free from oils or otherlubricants and with surface properties that generate high friction onthe outside surface of the guidewire 124. The guidewire 124 canbeneficially be constructed using outer surface that is non-lubricious.Thus the guidewire 124 can have at least a part of its outer surfacefree from coating with materials such as PTFE, Teflon, FEP, or the like.

FIG. 14A illustrates a detailed image of the distal end of themicrocatheter 100, with the expandable member 110 in its diametricallyexpanded state, further comprising the distal bond 112, the distal shaft116 further comprising the lumen 106, and the distal constriction 108.

Referring to FIG. 14A, the expandable member 110, in the illustratedembodiment, is a mesh or braid of filaments, the mesh being bonded tothe distal shaft 116 by the distal bond 112. The distal shaft 116 isshown in partial breakaway view to reveal the distal constriction 108.The mesh expandable member can be malleable, elastomeric or configuredas a spring, or it can be shape memory. The mesh 110, in its malleableconfiguration can be fabricated from annealed stainless steel, tantalum,gold, platinum, platinum-iridium, titanium, annealed cobalt nickelalloy, certain aforementioned polymers, and the like. In an embodimentwhere the mesh 110 is elastomeric, the fibers or filaments can befabricated from materials such as, but not limited to, spring hardnessstainless steel, cobalt nickel alloy, superelastic nitinol, shape memorynitinol, or the like. In certain elastomeric embodiments, the expandablemember or mesh 110 can be biased into its maximum diameter configurationso that upon removal of any stretching force, the expandable member 110assumes its maximum diameter configuration. In the case of nitinol, anaustenite finish (Af) temperature of about 20° C. or lower, andpreferably 15° C. or lower, is beneficial to maximize spring propertiesat body temperature. In embodiments where the expandable member 110comprises shape memory properties, the expandable member 110 can befabricated from nitinol and have an austenite finish temperature ofaround 28 to 32° C. in order to permit full expansion radially at aboutbody temperature of around 37° C. In the case of nitinol embodiments,either superelastic, pseudoelastic, or shape memory, the nitinolstructure can be shape set into the desired configuration to which itwill remain biased, near or above its austenite finish temperature. Inthe illustrated embodiments, removal of any external forces can includeremoving the guidewire 124 from within the lumen 106 of the distal shaft116.

The nitinol material, as described herein, is a nickel titanium alloy,which contains approximately 50% to 55.6% nickel. In a preferred bodyheat transition embodiment, the nitinol can be heat treated to set thetransition temperature at about 28 to 32 degrees centigrade. Shapesetting of the nitinol material into its activated configurationinvolves heating the final nitinol structure when constrained about amandrel or fixture that forces the nitinol structure into itssubstantially non-straight final shape, such as a coil, etc. The heatingcan be performed at temperatures ranging from about 480 degreescentigrade to 550 degrees centigrade with a preferred temperature rangeof about 500 to 525 degrees centigrade. The heating time can range fromabout 3 minutes to about 15 minutes or longer, although increasedheating time tends to increase the austenite finish transitiontemperature (Af).

FIG. 14B illustrates a detailed image of the distal end of themicrocatheter 100, with the expandable member 110 in its diametricallycompressed, longitudinally expanded state. The microcatheter 100 furthercomprises the distal bond 112, the distal shaft 116 further comprisingthe inner lumen 106, the distal constriction 108, and the guidewire 124.

Referring to FIG. 14B, the guidewire 124 is inserted through theconstriction 108, the frictional interference of which forces the distalshaft 116 to move distally to the extent possible and stretching theexpandable member 110 to the extent possible. The distal shaft 116 isshown in partial breakaway view to reveal the distal constriction 108.The individual fibers of the expandable member 110 can be seen in theirlongitudinally expanded configuration with the fibers being orientedmore axially or longitudinally than in FIG. 14A.

FIG. 15A illustrates a length of blood vessel 302 comprising a lumen 304and a wall 306. A microcatheter 100 has been inserted into the lumen 304and is being advanced toward a thrombus or thrombotic mass 308, which isthe target of the procedure. The microcatheter 100 comprises the outershaft 102, the expandable region 110, the distal shaft 116, the innershaft lumen 106, the distal constriction 108, and the guidewire 124. Themicrocatheter 100 can be advanced through a guide catheter (not shown),which serves as a tracking device to maneuver the microcatheter 100toward the therapeutic or diagnostic target 308.

FIG. 15B illustrates the blood vessel 302 wherein the microcatheter 100has been advanced through the target thrombus 308 and the thrombus 308is positioned over the expandable region 110. The microcatheter 100further comprises the outer shaft 102, the distal shaft 116, the innershaft lumen 106, and the guidewire 124. The blood vessel 302 is shown inpartial breakaway view.

FIG. 15C illustrates the blood vessel 302 wherein the expandable region110 has been dilated to its maximum diameter within the thrombus 308.Referring to FIGS. 3B and 3C, the diametric expansion of the expandableregion 110 was performed by removing the guidewire 124 from themicrocatheter 100. The expandable region 110, a spring biased mesh, hasself-expanded. Additional expansion could be generated by not fullywithdrawing the guidewire 124 but applying proximal force on the distalshaft 116 by friction coupling between the guidewire 124 and the distalconstriction 108 of FIG. 15A.

FIG. 16A illustrates the blood vessel 302 with the microcatheter 100advanced within the thrombotic mass 308 and the expandable region 110having been re-collapsed by re-insertion of the guidewire 124 throughthe distal constriction 108. A guide catheter 402 has been advanceddistally over the outer shaft 102. The guide catheter 402 furthercomprises a distal, adjustable flaring region 404, which is affixed tothe distal end of the tubing of the guide catheter 402.

FIG. 16B illustrates the blood vessel 302 with the microcatheter 100,further comprising the outer shaft 102 and the expandable region 110,being withdrawn proximally and taking with it the thrombotic mass 308,which has become entwined within the expandable region 110. Theadjustable flaring region 404 has been expanded at its distal end tocoerce, at least partially, the thrombus 308 and the expandable region110 inside the guide catheter 402. The guidewire 124 remains in placewithin the distal shaft 116 to maintain the stretched configuration ofthe expandable region 110. Once inside the guide catheter 402, thethrombus 308 can be constrained and remnants thereof can be preventedfrom flaking off and flowing back through the vasculature when the guidecatheter 402 and the microcatheter 100 are being removed from thevasculature.

Referring to FIG. 16B, the construction of the guide catheter 402 can bethe same as, or similar to, that of the microcatheter 100. The distalflaring region 404 can comprise radially expandable elements that can beactivated using shape-memory properties. The shape-memory properties canbe activated using body temperature or Ohmic heating to temperaturesabove that of body temperature. Upon removal of the higher temperatures,in the case of the Ohmic, or resistive, heating embodiments, the distalflaring region 404 can be made to assume a martensitic, or soft,characteristic conducive to removal of the guide catheter 402 from thevasculature 302. Such elevated temperatures can be generated byelectrical current applied across electrical leads that run from theproximal end of the guide catheter 402 to the distal end where they areconnected to each end of a nitinol expandable structure or tohigh-resistance wires such as those fabricated from nickel-chromiummetal. The high-resistance wires can be formed along, around, or throughthe nitinol structure to provide optimum heat transfer to the nitinol.The electrical energy can be applied at the proximal end of the guidecatheter 402 by the operator using batteries, or other electrical powersupply.

FIG. 17 illustrates a cranial portion of a human circulatory systemcomprising a descending aorta 502, an aortic arch 504, a left subclavianartery 506, a right subclavian artery 516, an innominate artery 514, aleft common carotid artery 508, a right common carotid artery 518, aleft external carotid artery 510, a right external carotid artery 520, aleft internal carotid artery 512, a right internal carotid artery 522, acerebrovascular aneurysm 524, a temporary neck bridge microcatheter 500,further comprising a catheter shaft 526, an expandable neck bridgeregion 530, and a guidewire 528.

Referring to FIG. 17, the microcatheter 500 has been routed from afemoral percutaneous insertion site (not shown) through the femoral andiliac arteries (not shown), and into the aorta 502, where it is nextadvanced through the innominate artery 514 and into the common carotidartery 518 and finally through the internal carotid artery 522 past theaneurysm 524 target site. The microcatheter 500 can have been routedthrough a guide catheter (not shown), placed during an earlier step inthe procedure. The primary purpose of the guidewire 528 is to controlthe expansion and contraction of the neck bridge expandable region 530,although it could also be used to assist with guiding the microcatheter500 to the target site. With the guide wire 528 removed, a separateembolic material delivery catheter (not shown) can be advanced throughthe guidewire lumen of the microcatheter 100 and be directed through theexpandable neck bridge 530 into the aneurysm 524.

FIG. 18 illustrates a portion of the left human carotid artery treecomprising the common carotid artery 518, the external carotid artery520, the internal carotid artery 522, and an aneurysm 524. Amicrocatheter 500, comprising a catheter shaft 526 and an expandablemesh 530, has been advanced toward the aneurysm 524 and a mesh 530 hasbeen expanded across the neck of the aneurysm 524 to form a neck bridgehaving porosity to blood and small diameter devices. An embolic coil 602is being deployed within the sac of the aneurysm 524 as part of anembolization procedure.

Referring to FIG. 18, the expandable mesh 530 is capable of forming aporous barrier across the neck of the aneurysm while maintaining bloodflow within the parent internal carotid artery 522. The expandable mesh530 comprises openings between the mesh elements or strands and theopenings are capable of passing small catheters, pushers, deliverydevices, and the like (e.g., therapeutic or diagnostic instruments)which can be directed to the aneurysm 524 for therapeutic or diagnosticpurposes. The guidewire 528, illustrated in FIG. 17, has been removedand replaced with the delivery system for the embolic coil 602. Thecatheter shaft 526 and the expandable mesh 530 are flexible and capableof bending around tortuous anatomy as is often found in thecerebrovasculature.

FIG. 19 illustrates a portion of the left human carotid artery treecomprising the common carotid artery 518, the external carotid artery520, the internal carotid artery 522, and an aneurysm 524. Amicrocatheter 500, comprising a catheter shaft 526 and an expandablemesh 530, has been advanced toward the aneurysm 524 and a mesh 530 hasbeen expanded across the neck of the aneurysm 524 to form a neck bridgehaving porosity to blood and small diameter devices. A volume of embolicmaterial 702 is being deployed within the sac of the aneurysm 524 aspart of an embolization procedure.

Referring to FIG. 19, the embolic material 702 is being deliveredthrough a liquid delivery catheter routed through the central lumen ofthe catheter shaft 526 following removal of any guidewires 528 such asthose illustrated in FIG. 5. The embolic material 702 is preferablyliquid or a very thin gel to permit injection through the liquiddelivery catheter. The embolic material 702 can comprise polymersdissolved within solvents such as DMSO or the like, wherein uponexposure to the body environment, the DMSO or other solvent is absorbedby body tissues leaving the polymeric mass to harden into a rigid orsemi-rigid embolic structure. Other embolic materials can comprisecyanoacrylate adhesives, tantalum powder, and other additives such aspolymeric agents, for example. The embolic material 702 can be usedalone or in conjunction with the coils 602 illustrated in FIG. 18. Thecatheter 500 used for this procedure, as illustrated in FIG. 17, neednot be substantially different from the catheter 500 used in theprocedure shown in FIG. 18.

FIG. 20 illustrates a more detailed view of the distal end of amicrocatheter 500 configured as a temporary neck bridge for an aneurysm.The microcatheter 500 comprises the mesh 530, the primary shaft 526, thesecondary, or distal, shaft 116 further comprising a lumen 106, a distalconstriction 108, a side window 814, a coil delivery catheter 812, acoil pusher 818, a coupler 816, and the embolic coil 602. Themicrocatheter 500 is illustrated deployed within a blood vessel 802further comprising a wall 804, a lumen 806, an aneurysm 808 furthercomprising an aneurysm neck 820, and a volume of flowing blood 810.

Referring to FIG. 20, the guidewire 528 of FIG. 17 is not illustratedbecause it is removed to create room for the coil delivery catheter 812and because its withdrawal from the distal constriction 108 permitsrecovery of the mesh 530 to its fully expanded configuration. The coildelivery catheter 812, or pusher, can further comprise a releasablecoupler 816 at its distal end that controllably and reversibly joins theembolic coil 602 to the coil delivery catheter 812. The coil deliverycatheter 812 is configured with a distal arc, or bend, so that uponexposure to the side window 814, the catheter 812 curves out of thewindow toward the aneurysm into which it can now be advanced. Thecatheter 812 is smaller in diameter than the openings in the mesh 530 topermit passage through the mesh filaments. The coil delivery catheter812 can be a guide for a pusher 818, as illustrated, or it can, itself,be the coil pusher 818. The coupler 816 can operate due to erosion of afusible link, release of a mechanical interlock, release of a frictionbond, electrolytic detachment, or the like.

The application of the microcatheter 500 as a porous neck bridge permitspartial closure of the neck 820 of the aneurysm 808, thus reducing flowwashout effects that could dislodge embolic material. The expandablemesh 530 is porous and permits blood to flow through the mesh 530following diametric expansion, thus maintaining distal perfusion. Thisis a superior technique to the prior art that involves total blockage ofthe neck 820 of the aneurysm 808 and parent vessel lumen 806 with aballoon during embolic material delivery. Such prior art total blockagecan last for periods of time in excess of those tolerable to cerebraltissues. Eliminating cerebral tissue ischemia facilitates better patientoutcomes following procedures where placement of a temporary neck bridgeacross an aneurysm 808 is indicated. Increasing the time of temporaryneck bridge placement eases the burden on the interventionalneuroradiologist and permits more accurate therapeutic procedures withsuperior patient outcomes. The microcatheter 500 can be configured toreach into the vasculature as far as the carotid siphon with an outsidediameter of around 2 to 4 French. The microcatheter can be configured toreach into the cerebrovasculature as far as the Circle of Willis andbeyond into the middle cerebral artery as far as the M1 bifurcation witha diameter of 1 to 3 French. The size of corresponding cathetercomponents can be scaled appropriately to the catheter outside diameter.

FIG. 21 illustrates an embodiment of the microcatheter 900 comprising aproximal shaft 902, a distal shaft 904, a serpentine adjustable lengthshaft 906, and an expandable region 530. The serpentine adjustablelength shaft 906 further comprises a plurality of fenestrations ports,or holes 914. The distal shaft 904 further comprises a central lumen 912and a constriction 108. The expandable region 530 further comprises aproximal bond 908 and a distal bond 910. The microcatheter 900 isillustrated being advanced inside a blood vessel 802 comprising a wall804, a lumen 806, an aneurysm 808, and a volume of flowing blood 810within the lumen 806.

Referring to FIG. 21, the expandable region 530 is being used as atemporary neck bridge to create a porous barrier across the neck of theaneurysm 808. The expandable region 530 is bonded to the proximal shaft902 by the proximal bond 908 and to the distal shaft 904 by the distalbond 901. The serpentine adjustable length shaft 906 is bonded, welded,integral to, or otherwise affixed to the proximal shaft 902 and thedistal shaft 904. The constriction 108 is affixed to the walls of theinterior lumen 912 of the distal shaft 904. The holes 914 are integralto the wall of the serpentine adjustable length shaft 906. The holes 914operably connect the interior lumen (not shown) of the serpentineadjustable length shaft 906 to the exterior environment around theoutside of the shaft 906, the environment being substantially within thevolume encompassed by the expandable region 530.

The expandable region 530 can comprise a mesh, as illustrated, or it cancomprise a plurality of longitudinal bars or struts spacedcircumferentially around the axis of the microcatheter 900. Theexpandable region 530 can, in other embodiments, comprise meshstructures at the proximal end, distal end, or both, and interconnectinglongitudinal struts between the mesh proximal and distal ends. Theserpentine adjustable length shaft 906 can comprise polymeric materialsor polymeric layered construction with a central reinforcement. Thepolymeric materials used in the serpentine adjustable length shaft 906can, in some embodiments, comprise elastomeric materials to permit theshaft 906 to assume a bias toward a pre-set configuration. The pre-setconfiguration can comprise a coil configuration or an undulating or wavyconfiguration. The pre-set configuration can be fabricated bymethodologies such as heat-setting, casting the tube over a spiralmandrel, etc. The shaft 906 is configured such that it can straightenout either by having its ends be placed in tension, as with a guidewirepushing on the constriction 108, by a substantially straight catheter(not shown) being inserted therethrough, or both. In a preferredembodiment, the expandable region 530 is in its radially collapsedconfiguration when the serpentine shaft 906 is in its straightenedconfiguration.

The holes 914 can be used for infusion of thrombolytic agents such as,but not limited to, urokinase, streptokinase, tissue plasminogenactivator (tPA), or the like. In other embodiments, the holes 914 canalso be used to infuse thrombogenic or embolic materials into ananeurysm 808 or for infusion of dye contrast agents for radiographicpurposes.

FIG. 22A illustrates a microcatheter 100 being advanced, over aguidewire 124, toward a partially occluding thrombus 1010 adherent tothe interior wall 306 of the blood vessel 302. The thrombus 1010partially occludes the lumen 304 causing stenosis of the blood flow 810.The microcatheter 100 further comprises the proximal shaft 102, thedistal shaft 116, the constriction 108, the lumen 106 of the distalshaft 116, and the expandable region 110.

Referring still to FIG. 22A, the expandable region 110 is collapsed toapproximately its minimum lateral profile by the distal force exerted bythe guidewire 124 against the constriction 108. The microcatheter 100 isbeing advanced, in some embodiments, using fluoroscopic monitoring andguidance with the aid of radiopaque markers strategically affixed to themicrocatheter 100.

FIG. 22B illustrates the microcatheter 100 having been advanced throughthe thrombus region 1010 with the radially collapsed expandable region110 placed approximately across the thrombus region 1010. The guidewire124 is illustrated still in place within the microcatheter 100 toprevent diametric expansion of the expandable region 110.

FIG. 22C illustrates the microcatheter 100 with its expandable region110 having been expanded by removal of the guidewire 124 (refer to FIG.22B). The microcatheter 100 further comprises the proximal shaft 102,the distal shaft 116 further comprising the lumen 106 and the pluralityof side holes 1002, and the constriction 108 being free from force sincethe guidewire is removed. The vessel 302 continues to support blood flow810 within its lumen since the expandable region is porous to the flowof blood, due to the large fenestrations between the mesh elements. Thethrombus 1010 is expanded radially outward to provide a central flowregion within the vessel 302 that is free from clinically relevantobstruction. In some embodiments, holes or openings 1002 in the wall ofthe distal shaft 116, disposed beneath the expandable region 110, can beused for the infusion of thrombolytic agents described in FIG. 21.During infusion of the thrombolytic agents, a distal plug (not shown),located near the constriction 108 can prevent escape of the thrombolyticagents out the distal end of the lumen 106. In another embodiment, theguidewire 124 can be configured with a diameter small enough to permitannular flow thereby, but plug or close the hole in the constriction 108to prevent substantial loss of agent through the distal end. Theembodiments described herein are especially suited to rapid treatment ofocclusive or ischemic stroke.

FIG. 23A illustrates a microcatheter 1100 being advanced toward ananeurysm 808 in a vessel 802. The vessel 802 further comprises a vesselwall 804, a vessel lumen 806, and a volume of flowing blood 810. Themicrocatheter 1100 further comprises a proximal shaft 1102, a distalshaft 1108, an expandable region 1104, and a guidewire 1110, which isshown inserted through the central lumen and which maintains thediametrically collapsed configuration of the expandable region 1104. Anembolic coil 1112 is illustrated partially lodged within the aneurysm808 with the proximal section 1114 of the coil 1112 having escaped intothe lumen 806 of the parent vessel 802. The expandable region 1104 isillustrated in its diametrically collapsed configuration. In theillustrated embodiment, the expandable region 1104 is a mesh structure.The proximal tail or section 1114 could generate thrombus,thromboemboli, or itself become fully dislodged and float downstream toembolize the lumen 806 of the parent vessel 802.

FIG. 23B illustrates the microcatheter 1100 with its expandable region1104 having been fully expanded radially in response to removal of theguidewire 1110. The microcatheter 1100 comprises the proximal shaft1102, the distal shaft 1108, the expandable region 1104, which is a meshin the illustrated embodiment, and a coil length adjusting region 1106.The vessel 802 comprises the wall 804, the lumen 806, the aneurysm 808,and the volume of flowing blood 810. The proximal tail 1114 of theembolic coil 1112 continues to protrude into the lumen 806.

FIG. 23C illustrates the microcatheter 1110 with a snare 1118 insertedthrough the central lumen of the microcatheter 1110. A guide catheter1120 has been advanced over the proximal shaft 1102, the guide catheter1120 further comprising a controllably, or selectively, flared distalend 1122. The snare 1118 has hooked the proximal tail 1114 of the coil1112 in preparation for proximal retraction into the flared guidecatheter 1120 and ultimate removal of the coil 1112 from the lumen 806of the parent vessel 802.

Referring to FIG. 23C, the flared distal end 1122 is affixed to thedistal end of the guide catheter 1120. The flared distal end 1122 can bean expandable structure configured with a braid or plurality oflongitudinal, bendable elements, and a pull-wire (not shown) which canbe used to axially contract the braid, resulting in radial expansion.Alternatively, in other embodiments, the flared distal end 1122 cancomprise nitinol shape-memory elements that expand in response toapplied electrical current and subsequent resistive heating, or it canexpand in response to exposure to blood at body temperature. In yetanother embodiment, the flared distal end 1122 can be made to expand inresponse to removal of a sheath, shroud, or jacket restraint.

FIG. 24A illustrates a microcatheter 1200 being advanced toward apartially dislodged tail or end 1114 of an embolic coil 1112. The coil1112 is placed in an aneurysm 808 in the wall 804 of a parent vessel802, further comprising a lumen 806 and filled with a volume of flowingblood 810. The microcatheter 1200 comprises a proximal shaft 1204, adistal shaft 1206, an expandable region 1202, and a guidewire 1110.

FIG. 24B illustrates the microcatheter 1200 with the guidewire 1110removed and the expandable region 1202 in a diametrically expandedconfiguration. The tail 1114 is trapped within the expanded mesh of theexpandable region 1202. In the illustrated embodiment, the expandableregion 1202 is a mesh. However, the expandable region 1202 can also beconfigured as a plurality of longitudinal bars, a serpentine stent-likestructure, a slotted tube, a wire basket, or the like. The microcatheter1200 comprises a serpentine length-adjustable element 906 as describedin the text accompanying FIG. 21.

FIG. 24C illustrates the microcatheter 1200 with the expandable region1202 in its diametrically collapsed or minimum profile configuration.The guidewire 810 has been inserted to straighten the length changingregion 906, engaging a constriction (not shown), or both, thus forcingthe axial length increase and diametric decrease in the mesh 1202. Thetail 1114 of the coil 1112 is trapped within the expandable region 1202and is in the process of being withdrawn from the aneurysm 808. A guidecatheter 1120 with a flared distal end 1122 has been advanced over theproximal shaft 1120 to assist with recovery of the misplaced emboliccoil 1112.

FIG. 25A illustrates a body vessel 302 with an obstruction 308 disposedtherein. A microcatheter 1300 has been advanced through the obstruction308 and an expandable member 1302 has been expanded diametrically. Themicrocatheter 1300 further comprises a proximal shaft 1310 and a distalexpandable member cover 1304.

Referring to FIG. 25A, the expandable member 1302 comprises a mesh,braid, plurality of longitudinal filaments, or the like. The expandablemember 1302 is covered, on its exterior, by the expandable member cover1304. The expandable member cover 1304 can be fabricated from a weave,braid, knit, or membrane, either porous or impermeable to liquids. Theexpandable member cover 1304 can be affixed to the interior of theexpandable member 1302 or to the exterior as illustrated. The expandablemember cover 1304 can be deployed inside the expandable member 1302 andbe tacked to the expandable member 1302 at a few points or not at all.The points of attachment can be configured to move or slide along thebars of the expandable member 1302 or the points of attachment can befixed. The expandable member cover 1304 can be elastomeric and biased toself-expand when the expandable member 1302 is expanded. The cover 1304is illustrated on the distal portion of the expandable member 1302 butthe cover can also be positioned on the proximal portion of theexpandable member 1302. The amount of expandable member 1302 partialcoverage can range from 20% to 75%. The partial expandable member cover1304 can be beneficial for procedures such as, but not limited to,trapping debris within the expandable member 1302 or for serving as afilter or protection device.

FIG. 25B illustrates a blood vessel 302 comprising an obstruction 308. Amicrocatheter 1320 has been advanced through the obstruction 308. Themicrocatheter 1320 comprises the proximal shaft 1310, the expandableregion 1302, an exterior mesh cover 1308, and an interior mesh cover1306.

Referring to FIG. 25B, in a preferred embodiment, the expandable region1302 would have either an exterior mesh cover 1308 or an interior meshcover 1306. The exterior mesh cover 1308, or the interior mesh cover1306, would preferably cover substantially the entire expandable region1302. In the illustrated embodiment, the exterior mesh cover 1308 isdisposed over only the proximal ½ of the expandable region 1302 whilethe interior mesh cover 1306 is disposed under only the distal ½ of theexpandable region. Such a configuration is made here for clarity.Materials suitable for fabricating the interior mesh cover 1306 or theexterior mesh cover 1308 include, but are not limited to, polyurethane,thermoplastic elastomer, silicone elastomer, polyester, polyimide,polyamide, PEEK, PEN, PTFE, or the like. The microcatheter 1310comprising the full expandable region cover 1306 or 1308 is suitable forpartial or complete occlusion of a vessel during a procedure forpurposes such as, but not limited to, flow reversal, stagnationgeneration, and the like. In yet another embodiment, the mesh coating orcover 1306 or 1307 can be disposed along the central, substantiallyuniform diameter part of the expandable region 1302 but not extendsubstantially onto the tapered end sections of the expandable region1302. In this embodiment, blood can continue to flow through the centerof the expandable region 1302 and through the tapered ends from, andinto, the parent vessel 302, while the cover 1306 or 1307 can serve tocompletely, or partially, block the neck or entrance to an aneurysm 808such as that illustrated in FIG. 24C. Such a device can be brought tobear quickly to prevent additional hemorrhage from a ruptured aneurysmon an emergency basis, for example. Furthermore, instrumentation can beintroduced through the lumen of the microcatheter to perform therapydistal to the expandable region.

FIG. 26 illustrates a partial breakaway, side view of an expandableguide catheter detailing the guide catheter proximal portion 2600. Theproximal portion of the expandable guide catheter comprises a length ofproximal tubing 2602, a slide dilator tube 2620, a length of obturatortubing 2616, a sheath hub 2650, a slide dilator hub 2652, an obturatorhub 2654, and a guidewire 2614. The slide dilator hub 2652 furthercomprises a hemostasis valve 2608 configured to provide a fluid-tightsliding seal against the shaft of a catheter, for example the obturatortubing 2616, inserted therethrough, or to provide a fluid-tight sealwith nothing inserted. The Sheath hub 2650 further comprises ahemostasis valve 2606 configured to provide a sliding seal against theslide dilator tube 2620 so as to prevent fluid loss or leakagetherebetween. The obturator hub 2654 further comprises a hemostasisvalve 2610 configured to seal against the guidewire 2614, or tocompletely close off with nothing inserted therethrough.

The proximal end of the slide dilator tube 2620 is affixed to the distalend of the slide dilator hub 2652. A central lumen extending through theslide dilator hub 2652 is operably connected to the central lumen of theslide dilator tube 2620 and to the central lumen of the hemostasis valve2608. The proximal end of the sheath proximal tube 2602 is affixed tothe distal end of the sheath hub 2650. The sheath hemostasis valve 2606is affixed near the proximal end of the sheath hub 2650 and the centrallumen of the sheath hemostasis valve 2606 is operably connected to thecentral lumen of the sheath hub 2650, which is also operably connectedto the central lumen of the sheath proximal tube 2602. The slide dilatortube 2620 is radially restrained but can move axially within the centrallumen of the sheath proximal tube 2602 under control of the user. Theobturator tube 2616 is configured to slide axially but be constrainedradially within the slide dilator tube 2620 central lumen, the slidedilator hub 2652 central lumen, and the slide dilator hemostasis valve2608 central lumen, such that the obturator tube 2620 can be removed andreplaced with a working catheter at a later time.

Materials suitable for fabrication of the slide dilator hub 2652, thesheath hub 2650, the obturator hub 2610, and all the hemostasis valvehousings 2606, 2608, 2610 include but are not limited to, polyurethane,polyethylene, polyvinyl chloride, PEEK, polysulfone, ABS, Hytrel,polyester, and the like. The material of the hubs can be selected tomatch properties of any tubes affixed thereto, such that the hubs can bewelded, insert-molded, ultrasonically welded, adhered using adhesive, orthe like.

FIG. 27A illustrates the expandable guide catheter distal end 2700 inits first, unexpanded, radially (or diametrically) contracted orcompressed state. The distal end 2700 comprises a proximalnon-expandable tube 2602, an obturator tube 2616 further comprising acentral lumen 2712, a transition zone 2704, an expandable outer sleeve2706, a nose cone 2708 further comprising a proximal taper 2710 and acentral lumen 2712, a translation dilator tube 2620 further comprising acentral lumen 2722, and a guidewire 2714.

Referring to FIG. 27A, the nose cone 2708 is affixed to the distal endof the obturator tube 2616 and the central lumen 2712 runs all the wayfrom the distal end of the nose cone 2708 through the proximal end ofthe obturator tube 2616 and any hubs affixed thereto. The translationdilator tube 2620 is slidably disposed within the lumen of the proximaltubing 2602. The distal end of the translation dilator tube 2620 isadvantageously beveled or rounded on its outer edge to minimize the riskof catching on the interior aspect of the transition zone 2704 or theexpandable outer sleeve 2706. In the unexpanded state, the distal end ofthe translation dilator tube 2620 is preferably retraced proximally to apoint proximal to the proximal end of the transition zone 2704. Theexpandable outer sleeve 2706 can comprise a single layer or a pluralityof layers. The layers of the expandable outer sleeve 2706 can befabricated from polymeric materials. The layers of the expandable outersleeve 2706 can be folded longitudinally to create pleats, they can beelastomeric and formed around a small mandrel with the capability ofelastomeric expansion upon imposition of internal dilator pressure, orboth. The layers of the expandable outer sleeve 2706 can comprisebraided, woven, knitted, or other known patterns of fabric. Thetranslation dilator tube 2620 can be fabricated from nitinol, stainlesssteel, titanium, PEEK, Pebax, Hytrel, polyimide, polyamide, polyester,or other suitable material. The distal end of the translation dilatortube 2620 advantageously comprises the qualities of kink resistance,flexibility, and column strength (or pushability). In an exemplaryembodiment, the translation dilator tube 2620 comprises an outsidediameter of approximately 3.2 French, an inside diameter ofapproximately 2.8 French, and a length of approximately 120-cm. Thetranslation dilator tube can be cut, laser cut, photo-etched, electrondischarge machined (EDM), or otherwise formed into a spiral cut, snakecut, or other structure with high column strength, high flexibility, anda thin wall.

FIG. 27B illustrates the expandable guide catheter distal end 2700 inits second, radially expanded state. The distal end 2700 comprises theproximal non-expandable tube 2602, the transition zone 2704, theexpanded expandable outer sleeve 2706, and the translation dilator tube2620 further comprising the central lumen 2722. The distal end 2700, inits diametrically expanded state, can comprise a substantially straightconfiguration, or it can comprise simple or complex curves along itslongitudinal axis.

Referring to FIG. 27B, the translation dilator tube 2620 has beenadvanced distally such that its distal end is proximate the distal endof the expandable outer sleeve 2706. The central lumen 2722 of thetranslation dilator tube 2620 comprises the central lumen of the entiredistal end 2700 of the guide catheter and is, in certain embodiments,the smallest lumen within the guide catheter since more proximal lumenscan be at least as large in diameter, or larger. The expandable outersleeve 2706 surrounds the translation dilator tube 2620 as a thin layer.

FIG. 28A illustrates an expandable guide catheter 2800 being advancedthrough a vessel 2804, further comprising a vessel lumen 2802, a volumeof flowing blood 2806, and a mass of thrombus 2808. The expandable guidecatheter 2800 further comprises a proximal shaft 2810, a transition zone2812, a distal expandable length 2814, a distal nose cone 2816, acentral lumen 2828, and a guidewire 2820.

Referring to FIG. 28A, the mass of thrombus 2808 has become lodgedwithin the vessel lumen 2802. The vessel lumen 2802 is bounded by theinterior of the vessel 2804. The vessel lumen 2802 contains flowingblood 2806. The mass of thrombus 2808 serves as a restriction to blockthe flow of blood 2806 with potentially catastrophic physiologicalconsequences to tissues distal to the mass of thrombus 2808. The mass ofthrombus 2808 can completely occlude the vessel lumen 2802 or it canpartially block the vessel lumen 2802.

The proximal shaft 2810 is an axially elongate tubular structurecomprising a proximal end, a distal end, and a lumen extendingtherethrough. The distal end of the proximal shaft 2810 is affixed, orintegral, to the transition zone 2810, which is a tapered, hollow,axially elongate structure. The distal end of the transition zone 2812is affixed, or integral, to the distal expandable length 2814, which isa hollow, axially elongate structure, further comprising a central lumen(not shown). The nose cone 2816 can be affixed to an inner shaft (notshown) slidably disposed along the inner or central lumen of the distalexpandable length 2814 and capable of being removed from the expandableguide catheter 2800. The nose cone 2816 and the inner shaft (not shown)further comprise an inner lumen 2818 capable of slidably receiving theguidewire 2820.

FIG. 28B illustrates the expandable guide catheter 2800 with its distalexpandable region 2814 and the transition zone 2812 enlarged to theirfull, maximum operating diameter within the vessel 2804, comprising thelumen 2802 and the thrombus 2808. The nose cone 2816, illustrated inFIG. 28A, has been removed by proximal retraction and is not visible.The expandable guide catheter 2800 comprises the proximal shaft 2810 anda dilator tube 2822, further comprising a central lumen 2824.

The transition zone 2812 has had its conical shape altered and is now agenerally cylindrical tube having approximately constant diameter alongits length. The dilator tube 2822, which was retracted proximal to thetransition zone 2812 in FIG. 28A, is illustrated advanced distally sothat its distal end resides generally at or near the distal end of theexpandable region 2814. The inner lumen 2824 of the dilator tube 2822describes the boundary through which catheters, debris, instruments, andother objects can pass. The dilator tube 2822 extends substantially fromthe distal end of the expandable region 2814 through and out theproximal end of any hubs (not shown) at the proximal end of the proximalshaft 2810. The proximal shaft 2810 can comprise constant bending andcolumn strength or the flexibility of the proximal shaft 2810 can varyfrom proximal end to distal end, either in steps, continuously, orcontinuously variable steps. The flexibility of the proximal shaft 2810advantageously can increase moving from the proximal end toward thedistal end of the proximal shaft 2810. The flexibility of the proximalshaft 2810 can be determined entirely by the proximal shaft 2810,entirely by the dilator tube 2822, or by a combination of both. Thedilator shaft or tube 2822 comprises sufficient column strength that itcan be advanced and retracted axially within the proximal shaft 2810with controllable force exerted by the user. The region between theproximal shaft 2810 and the dilator shaft 2822 as well as between thedilator shaft 2822 and the transition zone 2812 and the expandableregion 2814 can comprise enhanced lubricity to facilitate smooth,relative axial movement therebetween.

The materials comprising the expandable guide catheter can include, butnot limited to, PEBAX, PEEK, Hytrel, polyurethane, polyethylene, FEP,PTFE, silicone elastomer, and the like. The lubricious layer between thedilator tube 2822 and the rest of the device can comprise materials suchas, but not limited to, hydrophilic materials, silicone oil, PTFE, orthe like. The lubricious layer can be affixed to the dilator tube 2822,the proximal shaft 2810, the transition zone 2812, the expandable region2814, or a combination of the aforementioned. The proximal shaft 2810and the dilator tube 2822 can comprise monolithic materials or they cancomprise composite structures with outer layers and reinforcing layersembedded therein. Such reinforcing layers can include helical metal orpolymer coil windings, braided structures, longitudinal wires, spiralregions of reduced wall thickness, and the like. The transition zone2812, the expandable distal region 2814, or both, can compriselongitudinal folds or elastomeric structures to facilitate diameterchanges in response to the presence or absence of the dilator tube 2822.

FIG. 29A illustrates a microcatheter 2900 deployed through the innerlumen 2824 of the expandable guide catheter 2800. The microcatheter 2900comprises the proximal catheter shaft 2902, an expandable mesh 2904, anexpandable mesh proximal bond 2906, an expandable mesh distal bond 2908,and a length of distal tubing 2910. The guidewire 2820 is illustratedhaving been advanced through a central lumen of the distal tubing 2910.The expandable guide catheter 2800 comprises the proximal shaft 2810,the transition zone 2812, the expanded distal expandable length 2814,and the dilator tube or sliding dilator 2822 further comprising thecentral lumen 2824 and one or more vent slots 2922. The sliding dilator2822 is slidably disposed within the lumen of the guide catheter 2800.The sliding dilator 2822 can also be configured to rotate about itslongitudinal axis to present different structures toward a givencircumferential position. The microcatheter 2900, the sliding dilator2822 and the guide catheter 2800 advantageously comprise hubs (notshown) affixed to their proximal ends.

Referring to FIG. 29A, the thrombus 2808 is pierced by the microcathetershaft 2902 and expandable mesh 2904 is positioned, in its diametricallycollapsed configuration, distal to the occlusion or thrombus 2808. Theexpandable mesh 2904 is affixed, at its proximal end, to themicrocatheter shaft 2902 by the proximal mesh bond. The expandable mesh2904 is affixed, at its distal end, to the length of distal tubing 2910by the distal mesh bond 2908.

The microcatheter shaft 2902 and the length of distal tubing 2910 can befabricated from the same, or similar, materials as those used for theproximal sheath tubing 2810. The expandable mesh 2904 can be a braid orother mesh of polymeric or metal strands. Metallic materials suitablefor fabrication of the expandable mesh 2904 can include but are notlimited to, nitinol, stainless steel, cobalt-nickel alloys such asElgiloy®, titanium, or the like. Polymeric materials suitable forfabrication of the expandable mesh 2904 can include polyester,co-polyester, polyamide, polyimide, and the like. The strands of theexpandable mesh 2904 can comprise round, rectangular, triangular orother suitable cross-sectional shapes. A braid pattern comprisingbetween 1 and 4 ends per strand and between 10 and 60 strands over 360degrees can be used for the expandable mesh 2904. In an exemplaryembodiment, nitinol wire ranging in diameter from about 0.002 to 0.005inches can be used for this purpose. The nitinol can be superelastic,with a low austenite finish temperature, ranging below about 20 degreesCentigrade, in an exemplary embodiment. In other embodiments, thenitinol wire can have austenite finish temperatures above about 25 to 37degrees Centigrade and can be configured to have shape-memorycapabilities.

FIG. 29B illustrates the microcatheter 2900 of FIG. 29A with itsexpandable mesh 2904 having been diametrically expanded to its second,larger cross-sectional diameter that approximates that of the insidediameter of the vessel 2804. A length of catheter tubing 2916 that isdisposed intermediate the proximal mesh bond 2906 and the distal meshbond 2908 is biased toward and is illustrated having returned to aserpentine configuration that permits the proximal mesh bond 2906 andthe distal mesh bond 2908 to move axially closer together resulting inan increase in the diameter of the expandable mesh 2904. The serpentineconfiguration of the intermediate catheter tubing 2916 can, for example,occur in a single plane up and down or sideways, etc. lateral to thelongitudinal axis of the tubing 2916, it can form a spiral, or it canform other configurations. The intermediate catheter tubing 2916 isadvantageously configured so that it exerts less restorative force thanis exerted by a guidewire 2820 inserted therethrough, as illustrated inFIG. 29A, such that the intermediate catheter tubing 2916 configurationis governed by an inserted guidewire 2820 and forced generally straightand unbent. Removal of the guidewire 2820, as illustrated in FIG. 29B,results in the intermediate catheter tubing 2916 returning to itspre-biased serpentine configuration.

The axial shortening of the distance between the proximal and distalends of the expandable mesh 2904 permits, creates, forces, or generatesan increase in the diameter of the expandable mesh 2904, depending onwhether the expandable mesh 2904 is biased to its maximum diameter, itsminimum diameter, or an intermediate diameter. In an embodiment wherethe expandable mesh 2904 is biased to its largest diameter, the lengthdecrease can permit the mesh to enlarge without restriction. In anembodiment where the expandable mesh 2904 is biased to its smallestdiameter, the length decrease can force the mesh to enlarge, against itsinternal bias forces. In an embodiment where the expandable mesh 2904 isbiased to an intermediate diameter, the axial length decrease can permitthe mesh 2904 to enlarge somewhat and then force the expandable mesh2904 to expand to its maximum specified diameter. It is beneficial thatthe diameter of the expandable mesh 2904 approximate that of the insidediameter of the vessel 2804 so that it can form a complete barrierdistal to any clot or obstruction 2808. The openings in the expandablemesh 2904 are sized large enough to permit blood flow therethrough butsmall enough to trap or grab the occlusive material 2808.

The diameter of the expandable guide catheter 2800 is such that theinner lumen 2822 approximates that of the blood vessel lumen 2802. Ventholes 2920, numbering between 1 and 20 and sized between 0.005 and 0.050inches in diameter, in the guide catheter proximal shaft 2810 can passblood flow 2806 within the vessel 2804 if permitted by the obstruction2808. Similar holes, or longitudinally oriented slots 2922, in the slidedilator 2822 can be aligned to permit blood flow therethrough or rotatedout of alignment to block the flow of blood, gas, or other fluid. Bloodcan flow into the vent holes 2920, through the central lumen 2824 of theguide catheter 2800, and out the distal end through the annulus betweenthe guide catheter 2800 and the microcatheter shaft 2902.

FIG. 29C illustrates the expanded microcatheter 2900 of FIG. 29B beingwithdrawn proximally into the expanded guide catheter 2800. Withdrawalof the microcatheter 2900 and its expanded mesh 2904 proximally causesthe obstruction 2808 trapped therebetween to be coerced into the distalopening and into the lumen 2824 of the tube slide dilator 2822.Aspiration, or generation of a vacuum within the lumen 2824, canfacilitate removal of the obstruction 2808 from the vessel lumen 2802.Closure of the vent holes 2920 to maintain the vacuum at the distal endof the guide catheter 2800 can be accomplished by rotating non-ventedregions of the slide dilator 2822 to obstruct the vent holes 2920 in theproximal tubing 2810. The proximal end of the mesh 2904 is tapered toallow the mesh 2904 to be coerced into the lumen 2824. The obstruction2808 and the expandable mesh 2904 can be completely withdrawn into thelumen 2824 and out the proximal end of the guide catheter 2800. Another,or the same, catheter 2900 can be reinserted into the proximal end ofthe guide catheter 2800 and be advanced to the target region for repeator continued therapy or diagnosis.

FIG. 30 illustrates a region of cerebrovasculature 3000 with anexpandable guide catheter 2800 inserted therein over a guidewire 2820.The expandable guide catheter 2800 is shown comprising the proximaltubing 2810, the transition zone 2812, the distal expandable region2814, and the nose cone 2816. The cerebrovascular anatomy 3000 comprisesthe internal carotid artery 3004, the external carotid artery 3002, thecarotid siphon 3006, the middle cerebral artery 3008, the anteriorcerebral artery 3010, the anterior communicating artery 3012, theposterior cerebral artery 3014, the posterior communicating artery 3016,and a region of thrombus 3100 located in the anterior cerebral artery3010.

Referring to FIG. 30, the expandable guide catheter 2800 is illustratedwith its distal expandable region 2814 in its diametrically collapsed,small cross-sectional distal configuration such that it comprisesmaximum flexibility while maintaining column strength. The expandableregion 2814 is smaller in diameter than the proximal region 2810. Thetransition zone 2812 tapers between the diameter of the proximal region2810 and the expandable region 2814 at an angle of between 1 and 45degrees. The small diameter expandable region 2814 exhibits highflexibility and pushability and can, therefore, easily negotiate thetortuous carotid siphon 3006 in a way that larger catheters cannotachieve. In coordination with a J-tip guidewire 2820 or other suitablyshaped guidewire having a diameter of about 0.013 inches, 0.010 inches,or smaller, the expandable guide catheter 2800 can be advanced into thecircle of Willis, which is the region of the cerebrovasculatureanatomically distal to the carotid siphon 3006. The proximal region2810, which exhibits lower flexibility than the distal expandable region2814, resides in vessels exhibiting lower tortuosity, larger diameter,or both. The nose cone 2816 is removable and serves as a tapered leadingedge to help guide the guide catheter distal end 2814 into thevasculature.

FIG. 31 illustrates the expandable guide catheter 2800 with its distalexpandable region 2814 having been dilated to its full extent. Thevascular anatomy 3000 comprises the internal carotid artery 3004, thecarotid siphon 3006, the middle cerebral artery 3008, the anteriorcommunicating artery 3012, the posterior cerebral artery 3014, theposterior communicating artery 3020, and the anterior cerebral artery3010. The occlusion 3100 resides in the anterior cerebral artery 3010.The carotid siphon 3006 has straightened out and enlarged in diametersomewhat due to the presence of the expanded guide catheter distal end2814. An occlusion 3100, which can be a mass of thrombus, a misplacedmedical device, a region of atheroma, or the like, substantiallyoccludes the lumen of the anterior cerebral artery 3010. Any guidewiresare removed from the guide catheter 2800 at this time.

FIG. 32 illustrates the distal end of an expandable microcatheter 2900inserted through the expanded guide catheter 2800, through the occlusion3100, and with its distal end 2904 diametrically expanded. Theexpandable microcatheter 2900 comprises the proximal catheter shaft2902, the expandable mesh 2904, and the distal catheter shaft 2910. Thevascular anatomy 3000 comprises the internal carotid artery 3004, thecarotid siphon 3006, the middle cerebral artery 3008, and the anteriorcerebral artery 3010. The occlusion 3100 resides in the anteriorcerebral artery 3010. The microcatheter 2900 will next be withdrawnproximally, relative to the guide catheter 2800, to retrieve theobstruction 3100. After the obstruction 3100 is removed from thevasculature 3000, the microcatheter 2900 will be removed from the guidecatheter 2800. The guide catheter distal region 2814 will be collapseddiametrically by retracting the slide dilator 2822 proximally, afterwhich the guide catheter 2800 can be removed from the vasculature.

FIG. 33A illustrates a microcatheter 2900 deployed through the innerlumen 2824 of the expandable guide catheter 2800. The microcatheter 2900comprises the proximal catheter shaft 2902, an expandable mesh 2904, anexpandable mesh proximal bond 2906, an expandable mesh distal bond 2908,and a length of distal tubing 2910. The guidewire 2820 is illustratedhaving been advanced through a central lumen of the distal tubing 2910.The expandable guide catheter 2800 comprises the proximal shaft 2810,the transition zone 2812, the expanded distal expandable length 2814,and the dilator tube or sliding dilator 2822 further comprising thecentral lumen 2824 and one or more vent slots 2922. The sliding dilator2822 is slidably disposed within the lumen of the guide catheter 2800.The sliding dilator 2822 can also be configured to rotate about itslongitudinal axis to present different structures toward a givencircumferential position. The microcatheter 2900, the sliding dilator2822 and the guide catheter 2800 advantageously comprise hubs (notshown) affixed to their proximal ends.

The microcatheter 2900 is shown advanced into and through a thrombus2808 resident within the lumen of a body vessel 2804. Flood flow 2806 isrestricted by the presence of the thrombus 2808 so tissues distal to thethrombus 2808 are at risk for ischemia. The microcatheter 2900 is placedwithin the thrombus 2808 so that it can be expanded for the purpose offlow restoration within the lumen of the vessel 2804.

FIG. 33B illustrates the microcatheter 2900 of FIG. 33A with itsexpandable mesh 2904 having been diametrically expanded to its second,larger cross-sectional diameter that approximates that of the insidediameter of the vessel 2804. A length of catheter tubing 2916 that isdisposed intermediate the proximal mesh bond 2906 and the distal meshbond 2908 is biased toward and is illustrated having returned to aserpentine configuration that permits the proximal mesh bond 2906 andthe distal mesh bond 2908 to move axially closer together resulting inan increase in the diameter of the expandable mesh 2904. The serpentineconfiguration of the intermediate catheter tubing 2916 can, for example,occur in a single plane up and down or sideways, etc. lateral to thelongitudinal axis of the tubing 2916, it can form a spiral, or it canform other configurations. The intermediate catheter tubing 2916 isadvantageously configured so that it exerts less restorative force thanis exerted by a guidewire 2820 inserted therethrough, as illustrated inFIG. 33A, such that the intermediate catheter tubing 2916 configurationis governed by an inserted guidewire 2820 and forced generally straightand unbent. Removal of the guidewire 2820, as illustrated in FIG. 33B,results in the intermediate catheter tubing 2916 returning to itspre-biased serpentine configuration.

Following removal of the guidewire 2820 and diametric expansion of themesh 2904, the thrombus 2808 is compressed against the wall of thevessel 2804 thus permitting blood 2806 to flow more readily through thelumen of the vessel. Thus, in this configuration, temporary flowrestoration is accomplished within the blood vessel, thus minimizing therisk of ischemia to the patient. Injection of thrombolytic agentsthrough the microcatheter 2900 causes the thrombolytic agents to exitthrough the ports 914, proximate the thrombus 2808. The thrombolyticagents can dissolve or break up the thrombus 2808 to permit aspirationof the clot 2808 into the guide catheter 2800.

FIG. 34A Illustrates a side view of a microcatheter 3400 configured as athrombectomy or flow restoration device. The microcatheter 3400comprises a catheter shaft 3402 further comprising a slider window 3404,a hub (not shown), an expandable mesh 3406, a distal mesh bond 3408, aproximal mesh collar 3410, a slider 3412, a distal radiopaque marker3414, a distal mesh radiopaque marker 3416, and a slider to collar bond3418. The slider 3412 further comprises a central lumen 3420 and thecatheter 3400 rides over a small diameter guidewire 3422 that passesthrough the central lumen 3420 of the slider 3412. This embodiment, aswell as similar embodiments, has the advantage of exerting substantialradial forces outward to help ensnare or trap thrombus, as well as formoving the thrombus radially outward to create a permanent or temporaryflow restoration channel.

Referring to FIG. 34A, the slider 3412 is affixed to the proximal meshcollar 3410 by a weld, bond, pin, fastener, or the like 3418. The sliderto collar bond 3418 rides within a skive, window, fenestration,elongated hole, or the like 3404 in the catheter tubing or shaft 3402.The proximal slider to collar bond 3418 affixes the proximal end of themesh 3406 to the collar 3410. The collar 3410 is slidably disposed overthe outside of the catheter shaft 3402 and moves along the longitudinalaxis of the catheter shaft 3402, but is radially constrained not to moverelative to the catheter shaft 3402. The distal end of the mesh 3406 isaffixed to the catheter tubing 3402 by the distal mesh bond 3408. Thehub (not shown) is bonded, welded, or otherwise affixed to the proximalend of the catheter shaft 3402. The expandable mesh 3406 is fabricatedfrom nitinol, stainless steel, cobalt nickel alloy, polyimide,polyamide, polyester, or other high strength material. The wire diametercomprising the mesh 3406 can range between about 0.0005 and 0.006 incheswith a preferred range of about 0.001 to 0.004 inches. The mesh 3406 canalso comprise flat wire ranging in thickness between about 0.0005 to0.004 inches and in width between about 0.001 and 0.010 inches. In apreferred embodiment, the mesh 3406 is fabricated from superelasticnitinol that is shape set to be biased toward a cylindrical,diametrically collapsed configuration. The distal mesh radiopaque markeris affixed to, and stationary relative to, the distal end of the mesh3406 as well as the catheter shaft 3402.

In an exemplary embodiment, the slider 3412 has an internal diameter ofabout 0.012 inches and the inside diameter of the catheter shaft 3402 isabout 0.016 to 0.017 inches. The mesh 3406 can be about 1-cm to about5-cm long depending on the use of the device. The distance between thedistal mesh bond 3408 and the distal end of the catheter shaft 3402 canrange from about 1-cm to about 10-cm.

The slider 3412, in an exemplary embodiment can comprise a coil ofplatinum, stainless steel, tantalum, gold, titanium, nitinol, or thelike with an outside diameter of about 0.015 inches. The slider coil3412, having strand diameters ranging between about 0.001 to 0.003inches remains flexible along its length and does not detract from theflexibility of the distal end of the catheter shaft 3402. The collar toslider bond 3418 is maintained as short as possible, preferably between0.010 and 0.100 inches to maximize flexibility in the region.

The catheter shaft 3402, in an exemplary embodiment, comprises betweentwo and six discreet regions of flexibility with increasing flexibilitymoving from the proximal to the distal end of the catheter shaft 3402.The increasing flexibility can be generated by decreasing the modulus ofelasticity or hardness (durometer) of the polymer used in the shaft3402, as well as changing the stiffness of a reinforcing braid or coilencased therein.

FIG. 34B illustrates a side view of the microcatheter 3400 wherein thedistal expandable mesh 3406 has been expanded by distal motion of theproximal end of the mesh 3406 relative to the fixed distal end 3408 ofthe mesh 3406. The distal advance of the proximal end of the mesh 3406is generated through force applied by an annular sleeve 3430 surroundingthe guidewire 3422, wherein the annular sleeve 3430 exerts a force tomove the slider 3412, slidably disposed within the lumen of the catheter3402. The slider 3412 is affixed to an external collar 3410 by thecollar to slider bond 3418, which is in turn affixed to the proximal endof the mesh 3406. The collar 3410 and slider fixation element 3418protrudes through the window 3404 in the side of the catheter tubing3402, wherein the window 3404 completely penetrates the wall of thetubing 3402.

Referring to FIG. 34B, the annular sleeve 3430 can completely surroundthe guidewire 3422 or it can partially surround the guidewire 3422. Thepartially surrounding version of the sleeve 3430 comprises a generally“C”-shaped cross-section. The diametric clearance between the innerdiameter of the sleeve 3430 and the outer diameter of the guidewire 3422can range from about 0.0005 inches to 0.010 inches and preferablybetween 0.001 and 0.003 inches. The diametric clearance between theoutside diameter of the sleeve 3430 and the inside diameter of thecatheter tubing 3402 can range from about 0.0005 inches to about 0.010inches with a preferred range of about 0.001 and 0.005 inches.

The annular sleeve 3430 can comprise materials such as but not limitedto, polyimide, polyamide, PEEK, Hytrel, polyester, and the like. Theannular sleeve 3430 can comprise a reinforcing structure such as a coil,braid, or the like.

The window 3404 is preferably about as long as the projected travel ofthe collar 3410 with extra allowance to accommodate for the length ofthe collar 3410. For example, if the collar 3401 is projected to move0.300 inches and the length of the collar is 0.060 inches, the window3404 is preferably at least about 0.360 inches long. The circumferentialextent of the window 3404 can range from about 90 degrees to about 180degrees.

The bond 3418 between the collar 3410 and the slider 3412 can comprise apin, a weld, an adhesive joint, a silver solder joint, a combinationthereof, or the like. In an exemplary embodiment, the collar 3410 iswelded to the slider 3412 using a laser welder or a micro-tig welder.The length of the collar 3410 and the attachment joint 3418 isadvantageously minimized to maintain maximum flexibility of the collar3410 and slider 3412 assembly. The proximal end (not shown) of theannular sleeve 3430 extends to the proximal end of the catheter hub (notshown) and beyond so that the sleeve 3430 can be manipulated by the userrelative to the catheter hub (not shown). In a preferred embodiment, theproximal end of the annular sleeve 3430 comprises a knob, hub, orfitting (not shown) suitable for grasping and advance relative to thecatheter hub (not shown). In another embodiment, the sleeve hub (notshown) comprises a tubular projection that slides longitudinally withinthe catheter hub to maintain radial positioning and prevent buckling ofthe sleeve-guidewire combination within the catheter hub (not shown). Inyet another embodiment, the sleeve hub comprises a male Luer lockconfigured to releasably attach to a complimentary structure such as afemale Luer lock on the catheter hub (not shown).

The axial, or longitudinal, force applied by the user to the guidewire3422 is transmitted to the annular sleeve 3430, which is affixed to andsurrounds the guidewire 3422. The annular sleeve 3430, or other lateralenlargement affixed or integral to the guidewire 3422 moves the slider3412 in the distal direction, proximal direction, or both. This forcecan be measured using a force gauge (not shown) that can be affixed tothe hub or guidewire 3422 at the proximal end of the catheter hub (notshown). In an embodiment, the force gauge can be a strain-gauge typesystem electrically or operably coupled to a Wheatstone bridge or othertype of signal processor and then electrically amplified appropriatelyfor later readout or processing. The readout can be in the form of adigital display calibrated in units of force or an analog display. Inanother embodiment, the force gauge can be affixed directly, orindirectly, to the annular sleeve 3430 and the electrical output carriedby an electrical bus (not shown) running the length of the guidewire3422 such that it can be coupled to appropriate electrical signalconditioning wired to the proximal end of the guidewire 3422 or catheter3400.

The axial or longitudinal force imposed on the guidewire 3422 or annularsleeve 3430 to effect a diametric or lateral change in the size of themesh can be correlated to the amount of radial, lateral, or diametricforce or pressure is imposed by the mesh against vascular structureswhen it expands or contracts. Thus, axial forces measured or inferred bythe operator can be used to provide a readout or measurement of thelaterally directed forces generated by the mesh 3406 as it expands orcontracts. The differences between the lateral and longitudinal forcesis due to friction effects imposed on the guidewire 3422 relative to thecatheter or to the annular sleeve 3430 relative to the catheter 3400 andthe guidewire 3422 as well as the mechanical advantage generated by themesh structure 3406 as it expands laterally in response to longitudinalshortening. If the force is measured at the point where the guidewire3422 or sleeve 3430 pushes on the collar, then most, but probably notall, of the friction effects will be accounted for in the forcemeasurement. If the force is measured at the proximal end of thecatheter 3406, then the measured force will not account for the internalfriction of the system, which will otherwise need to be accounted for.

It is beneficial to understand the forces being applied for a number ofreasons. Excessive force can cause damage to the catheter system 3400 orto vascular structures. Inadequate forces can result in insufficientmesh 3406 expansion or lack of therapeutic effect. Thus, such feedbackon the amount of force being applied longitudinally to the system isuseful to the operator.

FIG. 34C illustrates a side view of the microcatheter 3400 wherein thedistal expandable mesh 3406 has been expanded diametrically by distalmotion of the proximal end of the mesh 3406 relative to the fixed distalend 3408 of the mesh 3406. The distal advance of the collar 3410, whichdrives the mesh 3406 is generated by advancing an activation guidewire3440, comprising a diameter or enlargement that is incapable of passingthrough the lumen of an axially elongate slider 3412 disposed within thelumen of the catheter tubing 3402.

Referring to FIG. 34C, the microcatheter 3400 comprises the cathetertube 3402, the window 3404, the distal radiopaque marker 3414, thedistal mesh bond 3408, the collar 3410, the slider 3412, and the mesh3406. The activation guidewire 3440 can be inserted following removal ofthe standard tracking guidewire 3422 (Refer to FIG. 34A). The trackingguidewire 3422 is small enough to fit through the central lumen or holein the slider 3412 and allows free motion of the catheter 3400thereover. The activation guidewire 3440 comprises features that allowit to displace the slider 3412 distally since it will not fit throughthe hole or lumen in the slider 3412.

FIG. 35A illustrates a proximal end of a thrombectomy or flowrestoration catheter 3400 comprising a hub 3502 further comprising afemale Luer lock fitting 3506, a strain relief 3504, the catheter tubing3402.

Referring to FIG. 35A, the hub 3502 comprises a central tapered lumenthat facilitates coercion of guidewires and other small cathetersdistally so that they are guided into the lumen of the catheter tubing3402. The guidewire 3422 is illustrated passing through the hub 3502 andinto the catheter tubing 3402. The catheter tubing 3402 is affixedwithin the hub 3502 using welding, insert molding, adhesive bonding,solvent bonding, or the like. A thru lumen is maintained without anysteps moving from proximal to distal within the hub 3502. The strainrelief 3504 comprises an elastomeric material that reduces stresses onthe catheter tubing 3402 where it exits the hub 3502. The hub 3502 cancomprise materials such as, but not limited to, polycarbonate,polysulfone, Grilamid®, polyurethane, ABS, and the like.

FIG. 35B illustrates a proximal end of a thrombectomy or flowrestoration catheter 3400 comprising the hub 3502, the female Luer lockfitting 3506, the strain relief 3504, and the catheter tubing 3402. Thecatheter 3400 further comprises an activation sleeve 3430 slidablydisposed over the guidewire 3422. The activation sleeve 3430 is affixed,at its proximal end, to a control cap 3510 further comprising anoptional male Luer lock fitting 3512. The activation sleeve 3430 isbonded, welded, adhesive bonded, solvent bonded, insert molded, or thelike to achieve the attachment to the cap 3510. A through lumen (notshown) is maintained all the way out the proximal end of the cap 3510 sothat the guidewire 3422 can exit out the proximal end of the cap 3510.The cap 3510 is affixed to the sleeve 3430 in a precise location so thatthe user can advance the cap and tighten it to the hub 3502 withoutneeding to worry about over-advancing the sleeve 3430 too far and thuscausing damage to the slider 3412 or collar 34210

FIG. 36A illustrates a catheter hub 3600 affixed to the proximal end ofthe catheter shaft 3402. The catheter hub 3600 comprises a “Y” connectorsuitable for injection of thrombolytic material into a sidearm port3606, which is terminated with a female Luer lock fitting 3608. Thecatheter hub 3600 can also comprise hemostasis valves 3622 such as, butnot limited to, Tuohy-Borst valves, pinhole valves, stopcocks, slitvalves, duckbill valves, a combination of these, or similar, toterminate the central port as well as the sidearm port 3606.

Referring to FIG. 36A, the catheter hub 3600 comprises a main body 3602further comprising the slider window 3620 and the slider lumen 3616, thesidearm port 3606 further comprising the Luer lock fitting 3608, thecontrol slider 3610, the slider handle 3618, the hemostasis valve 3622,the strain relief 3504, the catheter tubing to hub bond 3604, theactivation sleeve 3430, the activation sleeve to slider bond 3614, and aplurality of seals 3612.

The proximal end of the annular sleeve 3430 is affixed to the tubularslider 3610 slidably disposed within the lumen 3616 of the catheter hubbody 3602. The catheter hub 3600 comprises the sliding seals 3612, forexample “O”-rings, within the inside diameter of the catheter hub body3602 so that a fluid seal is maintained independent of axial location ofthe tubular slider 3610 within the catheter hub body 3602. A knob,button, trigger, handle, rotating collar, or the like 3618, can beaffixed, or fabricated integral to, the tubular slider 3610 to advanceor retract the tubular slider 3610 and the affixed sleeve 3430 relativeto the catheter hub 3600 thus controlling the motion and the extents orlimits of motion of the slider 3610 within the catheter hub body 3602.Referring to FIG. 34B, the motion of the proximal end of the mesh 3406,controlled by the sleeve 3430 is, thus, displacement limited at thecatheter hub 3600 so that excess force cannot be exerted on the fragileslider 3412 to collar 3410 and collar 3410 to mesh 3406 attachmentsthrough the sleeve 3430. The catheter hub body 3602, the tubular slider3610, or both, can comprise materials such as, but not limited to,polycarbonate, polysulfone, Grilamid®, polyurethane, ABS, and the like.The feature of displacement limited movement of the distal end of theannular sleeve 3430 relies on the annular sleeve 3430 having high columnstrength with insignificant compression and the catheter shaft 3402having insignificant linear expansion under tension. The braidedconstruction of the catheter shaft 3402 can help maintain low tensileelongation. Under 1 pound of linear force, the catheter 3402 stretchcombined with the shortening of the annular sleeve 3430 needs to be lessthan a total of 0.10 inches.

FIG. 36B illustrates a side view of an activation guidewire 3440. In anexemplary embodiment, the activation guidewire 3440 comprises a proximalregion 3630, a tapered transition zone 3632, an intermediate region3634, a flexible region 3638, a pusher bump 3640, and a distal region3642.

Referring to FIG. 36B, the proximal region diameter is about 0.014inches, stepping down, at the tapered transition zone 3632 to a diameterof about 0.012 inches, further comprising a 0.014 inch diameter pusherbump 3640 proximate the distal end of the 0.012 diameter flexible region3638, and then reducing to 0.009 to 0.011 inches in diameter for thedistal most region 3642, which has a length of about 1 to 20 cm.

The length of the bump 3640 can range from about 0.010 inches to 0.100inches or longer. The activation guidewire 3440 can comprise stainlesssteel, nitinol, fluoropolymer exterior layers, hydrophilic layers, andthe like. The distal most 10 to 30 cm of length 3638 can comprise a wirestepdown to a diameter of approximately 0.001 to 0.006 inches. A coil ofplatinum, tantalum, stainless steel, or other wire can surround theflexible region 3638 located distally to the intermediate region 3634.The coil within the flexible region 3638 can comprise wire withdiameters ranging from about 0.001 to 0.004 inches in diameter and theindividual coils are preferably spaced with 0 to 2 wire diametersbetween coils. The built-up or composite construction of the activationguidewire 3440 can comprise an outer layer of FEP, PFA, PTFE, or thelike that encapsulates the coil within the flexible region 3638. Thecoil composite structure can extend completely, or part-way into thedistal most region 3642 and can comprise a change in coil wire thicknessor spacing.

In another embodiment, the activation guidewire 3440 comprises a wirehaving a diameter of about 0.013 to 0.015 inches. In another embodiment,the activation guidewire 3440 comprises a main diameter of about 0.014inches except for the distal most about 1 to 20 cm, which is steppeddown to about 0.009 to 0.011 inches in diameter. In another embodiment,the activation guidewire 3440 comprises a proximal diameter of 0.012inches, an about 0.013 to 0.015 inch diameter step up proximate thedistal end of the 0.012 inch diameter, and then a distal most 0.09 to0.011 inch diameter in the distal most 1 to 20 cm of guidewire.

Referring to FIGS. 36B and 35B, the proximal end of the activationguidewire 3440 can comprise a hub, permanently or removably affixedthereto similar to the cap 3510. The proximal end of the activationguidewire 3440 can comprise a hub further comprising a male Luer lockfitting 3512 that is reversibly lockable with a complimentary fitting3506 on the proximal end of the catheter hub 3502. The position of thehub 3510 on the activation guidewire 3440 is selected and adjusted sothat when the activation guidewire hub 3510 is fitted or engaged againstthe catheter hub 3502, the distal end of the 0.014 inch diameter portionof the wire or the bump 3640 is advanced a pre-determined amount todisplace the slider 3412 a predetermined amount such that the entiresystem is displacement limited and cannot be overstressed by anoverzealous operator.

FIG. 37A illustrates the distal end of a thrombectomy, occlusionremoval, or flow restoration catheter 3400 comprising a slider coil 3412having an increased length extending in the distal direction. The distalend 3702 of the slider coil 3412 is spaced apart from the radiopaquemarker 3408 by the gap 3704. The purpose of the increased coil or slider3412 length is to provide a visual indicator of an indirect indicator ofthe expansion of the mesh 3406 when viewed under fluoroscopy, becausethe mesh 3406, itself, is generally not visible under fluoroscopy, evenin embodiments where the mesh 3406 is fabricated from metal because mostspring metals have poor radiopacity. By contrast, or in addition, adirect indication of expansion of the mesh 3406 can be achieved byaffixing small radiopaque markers near the longitudinal center of themesh 3406 and fluoroscopically observing the displacement of thesemarkers from the centerline of the mesh 3406.

FIG. 37B illustrates the distal end of the catheter 3400 of FIG. 37Ahaving the extended length slider 3412. The slider 3412 has beenadvanced distally, under force, or displacement, exerted by theguidewire 3440 against the proximal end of the slider 3412. Theexpandable mesh 3406 has expanded radially as the slider 3412 pushes thecollar 3410 distally. The collar 3410 is affixed to the proximal end ofthe mesh 3406. The mesh 3406 further comprises a plurality of radiopaquemarkers 3706 affixed proximate the longitudinal center of the mesh 3406.The markers 3706 can provide a direct indication of expansion of themesh 3406 since they are affixed to the central region of the expandableportion of the mesh 3406, the portion that is configured for thegreatest lateral expansion. The gap 3704 between the distal end 3702 ofthe slider 3412 and the second radiopaque marker 3408 has reduced tosubstantially zero, a situation that can be monitored under fluoroscopyby the user so that an indicator of full expansion of the mesh 3406 isvisible. The slider 3412 advantageously comprises radiopaque materialssuch as, but not limited to, platinum, gold, tantalum, platinum-iridium,and the like. The radiopaque materials can comprise the entire slider3412 or a portion thereof. In an exemplary embodiment, the distal most0.010 to 0.100 of the slider 3412 is radiopaque while the rest of theslider 3412 comprises malleable stainless steel, nitinol, or othersubstantially less radiopaque materials. The distal radiopaque part ofthe slider 3412 can be welded or crimped to the proximal, substantiallynon-radiopaque part of the slider 3412. The reduction in the gap 3704can advantageously be used to allow the user to observe the amount ofdistal advance of the mesh, by viewing the system under fluoroscopy.

The plurality of radiopaque markers 3706 can be small beads or massesfabricated from materials such as, but not limited to, tantalum,platinum, platinum-iridium, gold, and the like. The plurality ofradiopaque markers 3706 can have configurations that comprise loops ofround or flat wire, split shot, beads having a central hole, or thelike. The plurality of radiopaque markers 3706 is configured to detect,visualize, or illustrate, under fluoroscopy, the presence of, or thediametric or radial extent of, the expansion of the mesh 3406. In apreferred embodiment, the plurality of radiopaque markers number between1 and 10 and preferably between 2 and 8 at a given axial location on themesh. The plurality of radiopaque markers 3706 can be disposed at thecenter, the ends of the flat length, or both, of the mesh 3406.

FIG. 38 illustrates a flow restoration catheter 2900 deployed within athrombus 2808, which has become resident within the lumen of a bloodvessel 2804. The flow restoration catheter 2900 has been advancedthrough an expandable guide catheter 10 further comprising a transitionzone 32, a distal expandable region 34, and a slide dilator 50. The flowrestoration catheter 2900 further comprises the window 3404, the slidingcollar 3410, the expandable mesh 3800, and the catheter tubing 3402. Thecatheter tubing 3402 further comprises a length of longitudinallydisposed wire or strand 3802 embedded or affixed thereto.

Referring to FIG. 38, the catheter tubing 3402 has deployed along theside of the vessel 2804 and is not centered therein. The expandable mesh3800 has expanded asymmetrically but substantially has forced thethrombus open to generate a temporary flow lumen. The off-center accessto the thrombus 2808 can be beneficial because passage through thethrombus 2808 may be obstructed centrally but more open on a side. Themesh 3800 has sufficient expansion capabilities to compensate for theoff-center location of the main catheter tubing 3402. The main cathetertubing 3402 further is embedded with one or more stretch-resistantstrands 3802. The stretch-resistant strands 3802 can range in diameterfrom 0.0005 to 0.005 inches in diameter or major dimension. Thestretch-resistant strands 3802 can number between 1 and 10 and becircumferentially disposed about the catheter shaft 3402. The materialused to fabricate the stretch-resistant strands 3802 can include, butnot be limited to, stainless steel, tantalum, gold, platinum, platinumiridium, polyamide, polyimide, polyester, PEEK, polyurethane, or thelike. A single strand 3802 is shown embedded within the tubing 3402along its entire length, as in a co-extrusion or layup. The singlestrand 3802 passes on the other side of the tubing 3402 opposite thewindow 3404 so as to strengthen the tubing 3402 surrounding the window3404.

FIG. 39A illustrates the thrombectomy or flow restoration catheter 3400comprising the catheter shaft 3402, the slider 3412, the collar 3410,the collar to mesh bond 3418, the expandable mesh 3406, the cathetertube window 3404, and the proximal mesh to collar bond 3418. Alsoillustrated is an activation guidewire 3900 further comprising aslidable link 3902, a linkage lumen 3904, a deflector 3906, a sidewindow 3908, and a distal link tip 3910.

Referring to FIG. 39A, the guidewire 3900 is sized to pass slidablythrough the central orifice or lumen of the slider 3412. The slidablelink 3902 is slidably disposed within the linkage lumen 3904, integralto the guidewire 3900. The linkage lumen 3904 is terminated by thedeflector 3906, which is integral or affixed to the guidewire 3900. Thewindow 3908 is integral to the wall of the guidewire 3900 and operablyconnects the linkage lumen 3904 with the outside of the guidewire. Whenadvanced distally, distal end 3910 of the slidable link 3902 isdeflected laterally out the window 3908 such that it protrudes laterallyout the side of the guidewire 3900. With the distal end 3910 protrudingout through the window 3908, the activation guidewire 3900 engages theproximal end of the slider 3412 and can advance the slider distally whenthe guidewire 3900 is advanced distally, relative to the catheter shaft3402. This type of activation guidewire 3900 can permit complete freedomof motion of the catheter tubing 3402 and the slider 3412 relativethereto, but, following extension of the distal end 3910, can be used topush on the slider 3412 to move the proximal bond 3418 distally andexpand the mesh 3406.

FIG. 39B illustrates another embodiment of an activation guidewire 3920disposed within the thrombectomy or flow restoration catheter 3400. Thethrombectomy or flow restoration catheter 3400 comprises the cathetershaft 3402, the slider 3412, the collar 3410, the collar to mesh bond3418, the expandable mesh 3406, the catheter tube window 3404, and theproximal mesh to collar bond 3418. The activation guidewire 3920comprises a linkage 3922 disposed within a linkage lumen 3926, a distalend anchor 3924, and a plurality of outwardly bendable struts 3928.

As in FIG. 39B, the activation guidewire 3920 is configured to becomelarger in diameter or extend a portion laterally to engage the proximalend of the slider 3412 of the catheter 3400. The linkage 3922 isslidably disposed within the linkage lumen 3926 and is affixed to thedistal portions of the guidewire by the anchor 3924. The struts 3928 arethin regions in the wall of the guidewire 3920 that bend outward whentension is applied on the linkage 3922 to pull it proximally relative tothe guidewire 3920. The proximal tension on the linkage 3922 causescompression to be exerted on the struts 3928 causing them to bendoutward in response. The guidewire 3920 and its components can all befabricated from materials such as, but not limited to, stainless steel,nitinol, PTFE coatings, FEP coatings, PFA coatings, platinum-iridium,tantalum, and the like. A handle or tab (not shown) can be affixed tothe proximal end of the linkage 3922 and the guidewire 3920 to permitand control relative motion therebetween. A jack-screw or othermechanical advantage type control can be disposed between the guidewirehub and the linkage hub to control and provide high force to generatemotion therebetween.

FIG. 40A illustrates a radially or laterally collapsed thrombectomy orflow restoration catheter 4000 comprising a catheter tube 3402, a window3404, a proximal collar 3410, a slider tail 4008, a slider 4004, aslider radiopaque marker 4006, a distal mesh 3406 in its collapsedconfiguration, a distal mesh radiopaque marker 3408, a distal mesh bond3416, and a large diameter commercial guidewire 4002.

Referring to FIG. 40A, the commercial guidewire 4002 is being advanceddistally and has just reached the window 3404 in the catheter tubing3402. The mesh 3406 is elastomeric, shape memory, or superelastic, andis biased to its maximum length, minimum diameter configuration by itsown intrinsic restorative forces.

FIG. 40B illustrates a radially or diametrically expanded thrombectomyor flow restoration catheter 4000 comprising a catheter tube 3402, awindow 3404, a proximal collar 3410, a slider tail 4008, a slider 4004,a slider radiopaque marker 4006, a distal mesh 3406 in its expandedconfiguration, a distal mesh bond radiopaque marker 3408, a plurality ofmesh extent radiopaque markers 3706, a distal mesh bond 3416, and alarge diameter commercial guidewire 4002.

Referring to FIG. 40B, the guidewire 4002 has been advanced distally tojust contact the proximal end of the slider 4004, which is smaller ininside diameter than the outside diameter of the guidewire 4002. Theslider radiopaque marker 4006 is affixed to the distal end of the slider4004. The slider tail 4008 is affixed, or integral to, the proximal endof the slider 4004. In a preferred embodiment, the slider tail 4008 andthe slider 4004 are integrally formed from a single length of hypodermictube (hypo tube). The sides of the hypo tube are partially cut away toform the tail structure 4008 while the region where the hypotube is notcut away forms the axially elongate cylindrical slider 4004. The slider4004 and the slider tail 4008 can be fabricated from materialsincluding, but not limited to, stainless steel, platinum, gold,tantalum, cobalt nickel alloy, titanium, nitinol, and the like. Theslider radiopaque marker 4006 can be fabricated from materialsincluding, but not limited to, platinum, platinum iridium, tantalum,gold, barium or bismuth salts, or the like. The slider radiopaque marker4006 can be fabricated from round or flat wire formed into a coil, withthe wire having a width or diameter of approximately 0.002 inches andranging from about 0.0005 to 0.005 inches.

The guidewire, typically having a diameter ranging from about 0.012 to0.018 inches has been advanced distally past the slider tail 4008, whichplaces some off-center forces on the guidewire 4002 but still permitsthe guidewire 4002 to pass. The guidewire 4002 is advanced distallyuntil it abuts the proximal end of the slider 4004, after which itforces the slider 4004 distally to shorten the mesh 3406 and expand themesh 3406 diametrically. Since the slider 4004 is distal to the window3404, the guidewire 4002 is not coerced to exit through the window sinceit has already passed the window when it contacts the slider 4004.Furthermore, the slider tail 4008 serves as a moving blockade to preventthe guidewire 4002 from exiting the window 3404. In an exemplaryembodiment, the inside diameter of the slider 4004 can be about 0.012inches. In an exemplary embodiment, the inside diameter of the cathetertubing 3402 can range from about 0.016 to about 0.017 inches.

FIG. 41A illustrates the unexpanded, expandable guide catheter 10deployed within the lumen 2802 of the blood vessel 2804. The expandableguide catheter 10 further comprises the proximal non-expandable region33, a transition zone 32, a distal, expandable region 34, the slidedilator 50 further comprising the lumen 38, the guidewire 2614, the nosecone 2708 further comprising the central lumen 2818, and a ribcagereinforcing structure 4100.

Referring to FIG. 41A, the ribcage reinforcing structure 4100 isembedded within the wall of the distal region 34, the transition zone32, and optionally a portion or substantially all of the proximal region33. The ribcage reinforcing structure 4100 can be fabricated frommalleable materials such as, but not limited to, tantalum, stainlesssteel, titanium, gold, platinum, platinum-iridium, cobalt nickel alloy,or the like. The ribcage reinforcing structure 4100 can be compressed tocircumferentially surround the majority of the distal region 34, or aportion thereof. The ribcage reinforcing structure 4100 can beconfigured to not be fully embedded within any polymer surround of thedistal region 34 such that the ribs can slide circumferentially uponexpansion of the distal region 34 and the transition zone 32. Theribcage 4100 can provide pushability and torqueability to the system. Inthis diametrically collapsed configuration, the distal region 34 canretain significant flexibility and navigability through tortuousvasculature and can be advanced over the guidewire 2614.

FIG. 41B illustrates the expandable guide catheter 10 of FIG. 41A withthe distal region 34 expanded to its maximum operating diameter. Theguide catheter 10 comprises the proximal region 33, the transition zone32, the dilator 50 further comprising the central lumen 38, theguidewire 2614, and the ribcage reinforcement 4100 of FIG. 41A furthercomprising the longitudinally oriented spine 4104 and the ribs 4102. Theguide catheter 10 is deployed within the blood vessel 2804 furthercomprising the lumen 2802.

Referring to FIG. 41B, the distal region 34 is expanded by distaladvancement of the slide dilator 50 causing the central lumen 38 of thedilator 50 to comprise the effective central lumen of the guide catheter10. The ribs 4102 of the ribcage 4100 have opened up to form “C”-shapedstructures. The balance of the distal cross-section 34 is comprised bypolymeric material within which or against which the ribcage 4100 isaffixed. The fixation of the ribcage 4100 to the polymeric material issuch that the ribs are able to move circumferentially relative to thepolymeric material comprised by the distal region 34. The ribcage 4100has opened up diametrically, or radially, such that it now describes alarger diameter arc than in its collapsed configuration, as illustratedin FIG. 41A. The ribcage 4100 provides substantial support to a portionof the distal region 34 in both the longitudinal and circumferentialdirections. This support may be important when sliding the dilator 50distally to expand and proximally to contract the distal region 34.

FIG. 42A illustrates, in side cross-section and partial breakaway view,a region surrounding the proximal end of the expandable mesh 3406 of athrombectomy or flow restoration catheter 4200 having hydraulicactivation means. The catheter 4200 comprises the catheter tubing 3402,the slider or traveler 3412, the expandable mesh 3406, the collar 3410,the mesh to collar bond 3418, the window or skive 3404, a hydraulicplunger 4204, a catheter lumen 4202, one or more plunger seals 4206, anda guidewire 3422.

Referring to FIG. 42A, the guidewire 3422 is configured to slidably movewithin the catheter lumen 4202, the hydraulic plunger 4204, and theslider 3412. The slider 3412 is advantageously configured to be highlyflexible but retain column strength. In an exemplary embodiment, theslider 3412 is a closed coil spring, as illustrated and can furthercomprise a backbone (not shown) running axially and affixed thereto atone or more points. The hydraulic plunger 4204 seals around theguidewire 3422, which can be an about 0.010 inch diameter guidewire, orsimilar, and capable of passing entirely through the system withoutrestriction. The hydraulic plunger 4204 is affixed to the slider 3412 bywelding, adhesive bonding, mechanical fastening, or the like.

Pressurization of the catheter lumen 4202, which forms an annulusbetween the catheter tubing 3402 and the guidewire 3422, transmitspressure energy along the catheter length from the proximal end to thepoint of the hydraulic plunger 4202. Pressure can be applied at theproximal end of the catheter 4200 through a fluid infusion port 3608, asillustrated in FIG. 36 and be transmitted through the catheter lumen4202. The hydraulic plunger 4202, which slidably seals to the cathetertubing 3402 and the guidewire 3422 prevents escape of fluid pressure outthe distal end of the catheter 4200.

FIG. 42B illustrates the catheter 4200 with pressure applied to thecatheter tubing lumen 4202 and with the hydraulic plunger 4204 advanceddistally to approximately a limit point. The catheter 4200 comprises thecatheter tubing 3402, the slider or traveler 3412, the expandable mesh3406, the collar 3410, the mesh to collar bond 3418, the window or skive3404, the hydraulic plunger 4204, the catheter lumen 4202, one or moreplunger seals 4206, and the guidewire 3422.

Referring to FIG. 42B, the slider 3412 is affixed to the collar 3410,which is further affixed to the proximal end of the expandable mesh3406, said proximal end of the expandable mesh 3406 being free to moveaxially to the extent the window 3404 permits. The amount of pressureapplied can range between 1 PSI and 5,000 PSI depending on the surfacearea of the hydraulic plunger 4204. Application of pressure forces themesh 3406 to become axially compressed, thus increasing its diameter.The mesh 3406 can be fabricated from spring materials such as, but notlimited to, nitinol, titanium, cobalt-nickel alloy, stainless steel, andthe like. The mesh 3406 can be advantageously biased toward itsdiametrically compressed, axially elongated configuration. Release orevacuation of the fluid pressure, preferably generated by infusion ofsaline or radiopaque contrast dye or the like, permits the expandablemesh 3406, to return to its diametrically unexpanded, unstressed state.

In certain embodiments, methods of use are enabled by utilization of thedevices disclosed herein. In some embodiments, the vasculature isaccessed by a percutaneous or surgical incision into the groin. In apercutaneous method, a hollow, 18-gauge needle is inserted into afemoral or iliac artery, following which a guidewire is inserted throughthe hollow lumen of the needle and routed into the vasculature. Theneedle is next removed and an access sheath can be inserted over theguidewire and into the vasculature. The access sheath is typicallyterminated, at its proximal end, with a hemostasis valve to prevent lossof blood or influx of air into the vasculature. The expandable guidecatheter can next be inserted into the vasculature through the accesssheath or the expandable guide catheter can form the access sheathitself, without the need for a separate access sheath. The expandableguide catheter is next routed, along with the guidewire up the aortatoward the head of the patient. Interaction between a J-tip guidewireand the expandable guide catheter can be used for steering andmanipulation of the expandable guide catheter into the carotid arteriesor vertebral arteries. The extremely flexible distal end of theunexpanded, expandable guide catheter facilitates steering inconjunction with various guidewire distal end configurations since itcan be made straight or curved with relative ease. The expandable guidecatheter can be advanced through extremely tortuous vasculature such asthat found in the carotid siphon or the basilar artery and adjacentvessels such that the expandable guide catheter can be advanced with itsdistal end resident within the circle of Willis. Once the expandableguide catheter is positioned within the cerebrovasculature proximate atarget lesion, the guidewire can be removed. The expandable guidecatheter can next be expanded by distal advancement of the translationdilator. The dilator remains in place during the procedure. If, as inanother embodiment, a balloon dilator is used to expand the distal endof the expandable guide catheter, the balloon dilator is next deflatedand removed to expose the central lumen for catheter accesstherethrough.

In certain embodiments where blood flow re-establishment or clot removalis indicated, a therapeutic catheter, such as is described herein, isadvanced through the central lumen of the expandable guide cathetertoward the target lesion. Expandable elements at the distal end of thetherapeutic catheter are maintained in their radially collapsedconfiguration to minimize diametric profile during catheter advance. Incertain embodiments, the therapeutic catheter is advanced with aguidewire inserted through the central lumen to maintain a diametricallycollapsed configuration. The distal end of the therapeutic catheter isadvanced through or across the obstruction. The obstruction can be athrombus, clot, bolus of embolic material, misplace device, or the like.The distal end of the therapeutic catheter can next be deployed, ordiametrically expanded, by removing the guidewire proximally, causingthe biased therapeutic catheter tubing within the expandable distal endto become distorted into a serpentine or coil shape, thus shortening thelength of an expandable element and increasing its radius, diameter,cross-section, or other lateral dimension. In embodiments where theexpandable element is expanded within the obstruction, blood flow can beacutely re-established. Thrombolytic agents can be infused through ventswithin the expandable element, if desired, to dissolve, or assist withremoval of, any thrombus. In embodiments where the therapeutic device isan expandable mesh, malecot, coil, or other device, the expandableelement is configured so as not to be damaging to the vessel wall orintima.

In other embodiments, or in a further procedure using the sameembodiment of the device, the expandable element of the therapeuticcatheter can be radially collapsed, or re-collapsed, by distaladvancement of the guidewire therethrough, and positioned on the otherside (instrumentally distal) of the obstruction from the location of thedistal end of the expandable guide catheter. The mesh can be nextexpanded by proximal withdrawal of the guidewire. The therapeuticcatheter can then be withdrawn proximally toward the distal end of theexpandable guide catheter such that the expandable element engages theobstruction or clot and withdraws it toward and into the open end of theexpandable guide catheter, wherein it can be removed from the body.Vacuum, or suction, can be applied to the lumen of the expandable guidecatheter to provide aspiration effects to facilitate withdrawal of theobstruction into the lumen of the expandable guide catheter. Thetherapeutic catheter can be pulled proximally through and out of theexpandable guide catheter to remove the thrombus or obstruction afterwhich it can be re-inserted for follow-up therapeutic procedures. Theexpandable guide catheter can be removed from the body, preferablyfollowing proximal retraction of the translation dilator from theexpandable distal end to increase flexibility and suppleness of thedistal end. The expandable distal end of the expandable guide cathetercan become flaccid with the same diameter or it can resiliently bias toa smaller diameter by the urging of elastomeric elements disposedtherein. The expandable guide catheter can, in other method embodimentsbe withdrawn with the dilator retracted proximally and the therapeuticcatheter with trapped obstruction enclosed, or partially enclosed,within its lumen.

In other embodiments, the devices and methods disclosed herein can beconfigured or dimensioned for use throughout the vasculature, includingthe coronary and peripheral vasculature, the gastrointestinal tract, theurethra, ureters, Fallopian tubes, biliary tract ducts, and other bodylumens and potential lumens.

In other embodiments, the devices and methods disclosed herein can beconfigured to elute drugs from a mesh or temporary stent. In someembodiments, the mesh, or expandable element, which can be termed atemporary stent, can be coated with a layer of polymer such as, but notlimited to, Parylene, polyurethane, polyglycolic acid (PGA), polylacticacid (PLA), collagen, synthetic Glycocalix, phosphorylcholine, or thelike. The polymer layer can be impregnated with pharmaceutical agentssuch as, but not limited to, anti-cancer drugs, anti-inflammatory drugs,antimicrobial drugs, antibiotics, thrombolytic agents, or the like. Overtime, the drugs contained by the polymer layer can be designed toequilibrate or migrate out of the polymer layer and into the tissue, thebloodstream, or both. The drugs or other pharmacological agents can bedirected to perform tasks such as, but not limited to, retardation oftissue hyperplasia, retardation of thrombus buildup, dissolution ofthrombus buildup, and the like.

In other embodiments, the expandable structure or temporary stent can beconfigured to be covered with a polymeric coating, a polymeric membrane,a covering, or the like which spans elements of the expandablestructure. The covering can comprise a monolayer of polymer or it cancomprise a fabric such as a weave, knit, braid, or the like of materialssuch as, but not limited to, polyester (e.g. Dacron®), polyimide,polyamide, Hytrel, Pebax, or the like. The fabric or cloth covering canbe further coated or embedded with polymeric material such as, but notlimited to, polyurethane, silicone elastomer, thermoplastic elastomer,or the like. The pores in the fabric can be configured to be open withspaces up to 1-mm or larger therebetween, or the pores can besubstantially closed.

The expandable region can be configured to open regions of thrombus inthe vasculature, including in the coronary arteries or thecerebrovasculature. Such ability to open regions that have becomepartially or completely occluded with thrombus, clot, or atheromaprovides a temporary flow restoration device or stent. The unexpandeddevice is first advanced through the thrombus such that it substantiallyspans the thrombus region, following which the device is expandeddiametrically to open the thrombotic region and allow fluid, such as forexample blood, flow to resume therein. In some embodiments, theapparatus, devices, methods, and procedures can be used to open clots orthrombus, which blocks the lumen of stents or stent-grafts implantedwithin a body vessel or lumen. The devices and methods can beadvantageously used to open blockages in stents, neck bridges, or otherdevices placed within the cerebrovasculature, neurovasculature, andcoronary vasculature.

Such an expandable structure delivered by a catheter can be usedfollowing percutaneous transluminal coronary angioplasty (PTCA), plainold balloon angioplasty (POBA), or stenting in the coronary arteries orneurovasculature to deliver drugs to treat or prevent restenosis, reduceor treat inflammation, etc. The device for drug delivery comprises fluiddelivery lumens within the catheter that are operably connected toinjection ports on the catheter hub and operably connected to openingsin the catheter proximate the distal end of the catheter or proximatethe expandable region. Drugs delivered by the device which can serve asplatelet inhibitors include, but are not limited to, ticlopidine,clopidogrel, aspirin, and the like. Drugs delivered by the device can beused to treat restenosis and those drugs include, but are not limitedto, sirolimus, paclitaxel, methotrexate, everolimus, Biolimus A9,zotarolimus, and the like, and are generally of a group of drugs usedfor anti-cancer therapy. Drugs used to treat inflammation include, butare not limited to, aspirin, ibuprofen, naproxen sodium, steroids, andthe like. Drugs used to treat vessel cramping or vasoapasm includepapavarine, or the like. Drugs used to treat thrombosis include, but arenot limited to, tissue plasminogen activator, streptokinase, urokinase,lysokinase; staphylokinase, agents that convert plasminogen tofibrinolysin; fibrinolysin; fibrin modulatin, and the like.

In another embodiment of the methods of use, the catheter can be used toperform temporary neck remodeling of aneurysms or other vascularlesions. Often during coil embolization of aneurysms, the aneurismalnecks encountered are considered wide, necessitating the need for aneck-bridging device such as a temporary micro-balloon or an implantablestent. These neck-bridging devices hold the coils in place to preventthem from dropping into the parent vessel during delivery. Balloonsconform to the inner surface of the vessel wall and provide a smoothsurface against the coils, but seal the vessel from blood flow forperhaps long durations, such sealing having potentially catastrophicischemic consequences if sustained for too long a time. After fillingthe aneurysm with coils these micro-balloons are deflated and removedfor the vasculature. Neurological stents are permanent implants that canbridge the neck during the coiling procedure, they are expensive andnon-retrievable, but allow blood flow through them. The design/methodconcept disclosed herein would be to employ the microcatheter with theexpandable element positioned across the neck of the aneurysm andradially expand the element to provide the neck bridge. The element inthis case could be provided with a non-porous surface about thecylindrical outer surface portion enabling a smoother, non-open surfaceagainst the delivered embolization coils. Other embodiments can comprisea window, a skive, a hole, or a breach in the medial or distal portionof the catheter to allow the introduction of a coil delivermicro-catheter (coaxially) into the aneurysm. In this embodiment, thecatheter system may be slightly larger (3-Fr to 5-Fr) than the up to3-Fr diameter typical microcatheter.

In other embodiments, the microcatheter of FIG. 34 and FIG. 37 cancomprise an angiographic injection catheter routed through, or integralto, a central lumen of the microcatheter. The angiographic injectioncatheter can comprise a plurality of side holes near its distal end. Thedistal end of the angiographic injection catheter can be sealed orclosed off so that only lateral perfusion of angiographic dye can occurthrough the side holes when the dye is injected into a lumen of theangiographic injection catheter through an injection port at theproximal end of the angiographic injection catheter.

The angiographic injection catheter can be inserted through anobstruction and radiopaque dye can be injected through the catheter. Theradiopaque dye will exit through side ports that are exposed to theblood stream distal to any obstruction and through side ports that areexposed to the blood stream proximal to any obstruction through sideports so placed. Side ports within the obstruction will be blocked offby the obstruction, through the injection catheter is embedded, and dyewill not exit the catheter in that location. Fluoroscopic monitoring ofthe catheter will permit the viewer to gauge the length and location ofthe clot by the distance between the proximal and distal dye clouds.

FIG. 43 illustrates a microcatheter 4300, having angiographic injectioncapabilities, routed through an obstruction 2904. The microcatheter 4300is routed through the lumen 2802 of the vessel 2804. Radiographic dye4304 is being emitted under pressure from a distal exit port 4302 aswell as through a plurality of proximal dye exit ports 4306, distributedalong the length of the distal portion of the microcatheter 4300. Thedye exit ports 4302 and 4306 can be operably connected to the same lumenor to separate dye injection lumens comprised within the tubing 4308 ofthe catheter 4300. Under fluoroscopy, the gap between the proximal anddistal clouds of dye 4304 provides an indication of the extent of theobstruction 2904.

FIG. 43 illustrates a microcatheter 4300, having angiographic injectioncapabilities, routed through an obstruction 2818. The microcatheter 4300is routed through the lumen 2802 of the vessel 2804. Radiographic dye4304 is being emitted under pressure from a distal exit port 4302 aswell as through a plurality of proximal dye exit ports 4306, distributedalong the length of the distal portion of the microcatheter 4300. Thedye exit ports 4302 and 4306 can be operably connected to the same lumenor to separate dye injection lumens comprised within the tubing 4308 ofthe catheter 4300. Under fluoroscopy, the gap between the proximal anddistal clouds of dye 4304 provides an indication of the extent of theobstruction 2818.

Referring to FIG. 44A, the embodiment shown comprises six rails 4410 andsix gaps 4412 but the number of rails 4410 and gaps 4412 can range from2 to 20 or more. The rails 4410 can be affixed to the outer membrane4408 at one point, preferably in the proximal non-expandable region4402, along their entire length, or at any number of points. The outermembrane 4408 can be fabricated from polymeric materials in either sheetform or in the form of a woven, knitted, or braided fabric. The outermembrane 4408 can be elastomeric or it can be substantially inelasticand be folded in longitudinal creases when in its smaller diametercollapsed state. The rails can be fabricated from metals such as, butnot limited to, stainless steel, nitinol, titanium, cobalt nickel alloy,and the like. The rails can also be fabricated from polymers such as,but not limited to, PTFE, PFA, FEP, PET, PEEK, and the like. The railscan have a thickness of about 0.0005 to 0.005 inches. The rails can havewidths of about 0.001 to 0.010 inches.

FIG. 44B illustrates a translation dilator 4450 comprising a distalregion 4452 that is constructed from a solid tube 4456 using a helicalcoil construction fabricated by cutting completely through the wall of atube 4456, or partially therethrough. The tube 4456 can also comprise afine snake cut region 4454 disposed proximally to the helically coileddistal region 4452. A coarse snake cut region 4462 is disposed proximalto the fine snake cut region 4454. The designation of either coarse orfine depends on the axial distance between the windows 4458 cut into thetube 4456. The windows 4458 can be cut in one direction or in orthogonaldirections as illustrated in FIG. 44B. An unperforated region 4460 isdisposed proximally to the coarse snake cut region 4462. The more coarsesnake cut region 4462 is more flexible than the uncut region 4460 butless flexible than the fine snake cut region 4454, which is lessflexible than the helically coiled distal region 4452.

The tube 4456 is advantageously fabricated from drawn nitinol, which canbe superelastic or exhibit shape memory characteristics such that itreturns to a pre-defined shape above a transition temperature the rangeof which begins at a point called austenite start and ends at theaustenite finish temperature. When the temperature of the shape memorynitinol is above its austenite finish temperature, full recovery to thepre-defined shape should occur. In other embodiments, the tube 4456 canbe fabricated from titanium, stainless steel, titanium, cobalt nickelalloy, and the like. The tube 4456 can have a wall thickness rangingfrom about 0.0005 inches to 0.010 inches with a preferred range of about0.001 to 0.005 inches. The tube 4456 can have an outside diameterranging from about 1 French to about 10 French for neurovascularapplications with a preferred range of about 2 French to about 8 French.

The entire tubular structure can beneficially be covered with a highlylubricious polymeric layer 4464, illustrated as being peeled back offthe underlying snake cut and helically coiled regions. The polymericlayer 4464 can be fabricated from material such as, but not limited to,PTFE, FEP, PFA, PET, and the like. The entire structure can further, oronly, be coated with a hydrophilic material such as a hydrogel toincrease slipperiness and reduce friction. The polymeric layer 4464preferably does not comprise the windows or coiled cuts that exist inthe tube 4456 but in other embodiments, some or all of the windows,cuts, or the like can be incorporated into the polymeric layer 4464.

The axial length of the windows 4458 can range from about 0.005 to about0.100 inches, as can the spacing between the windows 4458. Theconstruction of the translation dilator 4450 is such as to maximizeflexibility near the distal end and maximize slipperiness (reducingfriction) while the translation dilator 4450 is being advanced distallyor withdrawn proximally to cause a diametric increase or decrease(respectively) in the distal expandable region of the expandable guidecatheter illustrated in FIG. 44A. The length of the helically cut regioncan range from about 1-cm to about 20 cm with a preferred range of about4 cm to about 15 cm. The length of the snake cut region can range fromabout 1 cm to about 30 cm or greater.

FIG. 45A illustrates a longitudinal cross-section of the distal portionof a therapeutic expandable guide catheter 4500, with its distal endradially collapsed, comprising a translation dilator 4502 furthercomprising a central lumen 4512, a proximal catheter tube 4504, adistal, radially expandable catheter tube 4506, a port or window 4508 inthe sidewall of the proximal catheter tube 4504, a port or window 4510within the wall of the translation dilator 4502, a transition zone 4514,and a central guidewire or obturator 4516.

Referring to FIG. 45A, the proximal catheter tube window 4508 and thetranslation dilator window 4510 can be kept aligned using radiopaquemarkers 4518 with circumferential asymmetry. The alignment can also bemaintained by affixing or integrating indexing guides (not shown) to theguide catheter 4500, wherein the indexing guides prohibitcircumferential misalignment of the translation dilator 4502 and theproximal catheter tube 4504. The indexing guides can be rails disposedalong the length of the proximal catheter tube 4504 or they can bekeyholes in the proximal catheter tube 4504 hub (not shown) that engagewith features on the translation dilator 4502 to maintaincircumferential alignment.

FIG. 45B illustrates the therapeutic expandable guide catheter 4500 withits translation dilator 4502 having been advanced distally such that thedistal, radially expandable catheter tube 4506 has become diametricallyincreased in size or cross-section. The guidewire or obturator 4516 ofFIG. 45A has been removed. The port or window 4508 in the proximalcatheter tube 4504 is aligned with the port or window 4510 in thetranslation dilator 4502. The distal end of the translation dilator 4502holds the distal end of the expandable sheath tubing 4506 in the open,radially expanded configuration. Radiopaque markers 4520 at the distalends of both the translation dilator 4502 and the distal sheath tube4506 can be used, under fluoroscopic visualization, to show when thetranslation dilator 4502 is fully advanced to the distal end of theexpandable sheath tubing 4506. The windows 4510 and 4508 can be skived,milled, etched, drilled, or otherwise cut into the sidewalls of therespective axially elongate tubing members 4502 and 4504.

FIG. 46A illustrates a vessel 4600 comprising a vessel wall 4602, avessel lumen 4604, an obstruction 4608, and a volume of blood 4610. Theblood 4610 is shown with arrows as if it is flowing from left to rightin the vessel, however, with the obstruction 4608, the flow rate is verylow or substantially nonexistent, as depicted by the short length of thearrows associated with the blood 4610.

FIG. 46B illustrates the therapeutic expandable guide catheter 4500having been advanced through the obstruction 4608 with the distal end ofthe expandable guide catheter 4500 exposed and unobstructed within thevessel lumen 4604 distal to the obstruction 4608. The blood 4610 isstill flowing slowly, or at clinically unacceptable levels and ispossibly causing tissue ischemia in regions distal to the blockage 4608.The translation dilator 4502 is withdrawn into the proximal guidecatheter tubing 4504 and is not dilating the distal region 4506.

FIG. 46C illustrates the therapeutic guide catheter 4500 with theguidewire 4516 having been removed and the distal end expanded radiallyby distal advancement of the translation dilator 4502 (Refer to FIG.45A). The port 4508 in the proximal catheter tube 4504 is sufficientlyaligned with the port 4510 in the translation dilator 4502 that fluidcommunication between blood on the outside of the catheter 4500 and thecentral lumen of the translation dilator 4502 is established. Blood 4610is flowing into the windows 4508 and 4510, through the central lumen ofthe translation dilator 4502, and out into the vessel lumen 4602distally to the obstruction 4608. Blood 4610 is flowing into the centrallumen 4512 of the translation dilator 4502, flowing through the centrallumen 4512 and flowing out the distal opening of the central lumen 4512and into the vessel lumen 4602 where it can perfuse downstream tissues,thus relieving tissue ischemia. The obstruction 4608 has been penetratedand expanded radially by the distal expandable region 4506 of the guidecatheter 4500. Thus, the guide catheter 4500 comprises a shunt for thevessel lumen 4512.

FIG. 46C illustrates the therapeutic guide catheter 4500 with theguidewire 4516 having been removed and the distal end expanded radiallyby distal advancement of the translation dilator 4502 (Refer to FIG.45A). The port 4508 in the proximal catheter tube 4504 is sufficientlyaligned with the port 4510 in the translation dilator 4502 that fluidcommunication between blood on the outside of the catheter 4500 and thecentral lumen of the translation dilator 4502 is established. Blood 4610is flowing into the windows 4508 and 4510, through the central lumen ofthe translation dilator 4502, and out into the vessel lumen 4602distally to the obstruction 4608. Blood 4610 is flowing into the centrallumen 4512 of the translation dilator 4502, flowing through the centrallumen 4512 and flowing out the distal opening of the central lumen 4512and into the vessel lumen 4604 where it can perfuse downstream tissues,thus relieving tissue ischemia. The obstruction 4608 has been penetratedand expanded radially by the distal expandable region 4506 of the guidecatheter 4500. Thus, the guide catheter 4500 comprises a shunt for thevessel lumen 4604.

What is claimed is:
 1. A catheter system comprising; an outer shaft(3402) characterized by a proximal end and a distal end and an outershaft wall, said outer shaft having a first lumen extending from theproximal end to the distal end thereof, said lumen having a firstdiameter; an inner, distal shaft (3412) characterized by a proximal endand a distal end, said inner, distal shaft disposed within the outershaft; an expandable member (3406) characterized by a proximal end and adistal end, said expandable member secured at its distal end to thedistal end of the outer shaft and secured at its proximal end to theinner, distal shaft; wherein the expandable member is expanded andcontracted by relative movement of the outer shaft and the inner, distalshaft, and wherein a longitudinal window (3404) is disposed in the outershaft wall, proximate the proximal end of the expandable member, (3406)and the proximal end of the expandable member is fixed to the inner,distal shaft (3412) through the longitudinal window.
 2. The cathetersystem of claim 1, further comprising a collar (3410) affixed to theproximal end of the expandable member (3406) and affixed, through thelongitudinal window, to the distal shaft.
 3. The catheter system ofclaim 1, further comprising an activation guidewire (3440) slidablydisposed within the outer shaft, said activation guidewire beingoperable to push the distal shaft proximally to cause radial expansionof the expandable member.
 4. The catheter system of claim 1, wherein thedistal shaft comprises a second lumen extending from the proximal end tothe distal end of the distal shaft.
 5. The catheter system of claim 1,wherein the distal shaft terminates proximally within the distal end ofthe outer shaft.
 6. The catheter system of claim 1, further comprising aguide catheter, wherein the guide catheter further comprises a flareddistal opening.
 7. The catheter system of claim 1, further comprising aguide catheter, wherein the guide catheter further comprises a flareddistal opening, said flared distal opening comprising a radiallyexpandable shape memory element.
 8. The catheter system of claim 1,further comprising a cover (1304) disposed on a distal portion of theexpandable member, said cover being impermeable to liquids.
 9. Thecatheter system of claim 1, further comprising a cover (1306) disposedon the entirety of the expandable member, said cover being impermeableto liquids.
 10. The catheter system of claim 1, wherein the inner,distal shaft is characterized by a side window (814) communicating fromthe lumen to the exterior of the inner, distal shaft, said side windowdisposed within the expandable member.
 11. The catheter system of claim1, wherein the expandable member is self-expandable, and has a first,small diameter configuration when tensioned by a guidewire inserted intoa constriction in the guide catheter distal to the expandable member anda second, large diameter configuration when not tensioned by a guidewiredisposed in the constriction.
 12. A catheter system comprising; an outershaft (3402) characterized by a proximal end and a distal end and anouter shaft wall, said outer shaft having a first lumen extending fromthe proximal end to the distal end thereof, said lumen having a firstdiameter; an inner, distal shaft (3412) characterized by a proximal endand a distal end, said inner, distal shaft disposed within the outershaft; an expandable member (3406) characterized by a proximal end and adistal end, said expandable member secured at its distal end to thedistal end of the outer shaft and secured at its proximal end to theinner, distal shaft; wherein the expandable member is expanded andcontracted by relative movement of the outer shaft and the inner, distalshaft, and further comprising a sleeve (3430) slidably disposed withinthe outer shaft, said sleeve (3430) being operable to push the inner,distal shaft distally to cause radial expansion of the expandablemember.
 13. The catheter system of claim 12, wherein the sleeve has alumen extending from the proximal end to the distal end of the sleeve,said lumen sized to accommodate a tracking guidewire (3422).
 14. Thecatheter system of claim 13, wherein the distal shaft has a lumenextending from the proximal end to the distal end of the distal shaft,said lumen sized to accommodate the tracking guidewire (3422).
 15. Thecatheter system of claim 12, wherein the sleeve (3430) extends to theproximal end of the catheter, and is operable from the proximal end ofthe catheter to slide within the outer shaft.
 16. The catheter system ofclaim 12, wherein the distal shaft comprises a second lumen extendingfrom the proximal end to the distal end of the distal shaft.
 17. Thecatheter system of claim 12, wherein the distal shaft terminatesproximally within the distal end of the outer shaft.
 18. The cathetersystem of claim 12, further comprising a guide catheter, wherein theguide catheter further comprises a flared distal opening.
 19. Thecatheter system of claim 12, further comprising a guide catheter,wherein the guide catheter further comprises a flared distal opening,said flared distal opening comprising a radially expandable shape memoryelement.
 20. The catheter system of claim 12, further comprising a cover(1304) disposed on a distal portion of the expandable member, said coverbeing impermeable to liquids.
 21. The catheter system of claim 12,further comprising a cover (1306) disposed on the entirety of theexpandable member, said cover being impermeable to liquids.
 22. Thecatheter system of claim 12, wherein the inner, distal shaft ischaracterized by a side window (814) communicating from the lumen to theexterior of the inner, distal shaft, said side window disposed withinthe expandable member.
 23. The catheter system of claim 12, wherein theexpandable member is self-expandable, and has a first, small diameterconfiguration when tensioned by a guidewire inserted into a constrictionin the guide catheter distal to the expandable member and a second,large diameter configuration when not tensioned by a guidewire disposedin the constriction.
 24. The catheter system of claim 12, furthercomprising a collar (3410) affixed to the proximal end of the expandablemember (3406) and affixed, through the longitudinal window, to thedistal shaft.
 25. The catheter system of claim 12, further comprising anactivation guidewire (3440) slidably disposed within the outer shaft,said activation guidewire being operable to push the distal shaftproximally to cause radial expansion of the expandable member.